Evaluation of the Efficacy and Tolerance of a Light Therapy Mask on Mild to Moderate Brown Spots and Moderate to Severe Facial Wrinkles

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03312543
• Collaborator: (none)
• Enrollment: 124
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 21.1

Study Details

Study Description

Brief Summary

This research study will test how well a light therapy mask works for women with mild to moderate hyperpigmentation (brown spots) and moderate to severe facial wrinkles, as compared to a "sham" or inactive investigational light therapy mask. The study will also test if the light therapy mask causes any irritation. For the first 12 weeks of the study, participants will use the assigned mask, along with a provided cleanser and sunscreen. For the second 12 weeks of the study, participants will use just the cleanser and sunscreen.

Condition or Disease	Intervention/Treatment	Phase
Skin Aging	Device: Active Mask; Device: Sham Mask	N/A

Detailed Description

Exposure to sunlight and artificial light sources containing ultraviolet (UV) radiation is known to accelerate the skin's aging process, resulting in unwanted wrinkles, irregular skin tone, and loss of elasticity. Ablative techniques, such as dermabrasion, deep chemical peels, and ablative laser resurfacing of various wavelengths, are well documented to alleviate the signs of photodamage. However, such techniques often require significant post-treatment care and have higher risk profiles than other treatments, with potential side effects including erythema, pigmentation issues, infection, and possible scarring. They may be poorly tolerated by patients who dislike the discomfort, wound care, and prolonged downtime involved.

Non-ablative skin rejuvenation procedures are also effective for improving the appearance of photodamaged skin and are becoming increasingly popular because of their minimal downtime and increased safety. These procedures include intense pulsed light systems, non-ablative lasers, and monochromatic light boxes, which can target facial rhytids, irregular pigmentation, telangiectasia, and skin laxity. Unfortunately, such techniques can be expensive and their use is primarily limited to clinical settings.

However, the light-emitting diode (LED) is a novel light source that is well-suited for non-ablative phototherapy that can be utilized at home for a relatively low price. This study will evaluate the efficacy and tolerance of an LED-based light therapy mask as compared to a sham mask in subjects seeking anti-aging benefits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Evaluator-Blinded Clinical Study to Evaluate the Efficacy and Tolerability of an Investigational Light Therapy Mask on Subjects With Mild to Moderate Mottled Hyperpigmentation and Moderate to Severe Facial Wrinkles
• Actual Study Start Date: Oct 9, 2017
• Actual Primary Completion Date: Jan 12, 2018
• Actual Study Completion Date: Apr 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Cell: Active Mask Cleanser, Moisturizer, Active Mask	Device: Active Mask; A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the active light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.; Other Names: Active Light Therapy Mask
Sham Comparator: Sham Cell: Sham Mask Cleanser, Moisturizer, Sham Mask	Device: Sham Mask; A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the sham light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.; Other Names: Sham Light Therapy Mask

Outcome Measures

Primary Outcome Measures

1. Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores [Baseline to Week 12]

   3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

2. Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1 [Baseline to Week 12]

   Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually.

3. Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2 [Baseline to Week 12]

   Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually.

4. Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3 [Baseline to Week 12]

   Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually.

Secondary Outcome Measures

1. Global Wrinkling - Change From Baseline to Week 1 [Baseline to Week 1]

   3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

2. Global Wrinkling - Change From Baseline to Week 4 [Baseline to Week 4]

   3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

3. Global Wrinkling - Change From Baseline to Week 24 [Baseline to Week 24]

   3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

4. Fine Lines - Change From Baseline to Week 1 [1 week]

   3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

5. Fine Lines - Change From Baseline to Week 4 [Baseline to Week 4]

   3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

6. Fine Lines - Change From Baseline to Week 12 [Baseline to Week 12]

   3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

7. Fine Lines - Change From Baseline to Week 24 [Baseline to Week 24]

   3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

8. Periorbital Wrinkles - Change From Baseline to Week 1 [Baseline to Week 1]

   3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

9. Periorbital Wrinkles - Change From Baseline to Week 4 [Baseline to Week 4]

   3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

10. Periorbital Wrinkles - Change From Baseline to Week 12 [Baseline to Week 12]

    3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

11. Periorbital Wrinkles - Change From Baseline to Week 24 [Baseline to Week 24]

    3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

12. Surface Roughness - Change From Baseline to Week 1 [Baseline to Week 1]

    3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

13. Surface Roughness - Change From Baseline to Week 4 [Baseline to Week 4]

    3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

14. Surface Roughness - Change From Baseline to Week 12 [Baseline to Week 12]

    3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

15. Surface Roughness - Change From Baseline to Week 24 [Week 24]

    3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

16. Uneven Skin Tone - Change From Baseline to Week 1 [Baseline to Week 1]

    3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

17. Uneven Skin Tone - Change From Baseline to Week 4 [Baseline to Week 4]

    3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

18. Uneven Skin Tone - Change From Baseline to Week 12 [Baseline to Week 12]

    3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

19. Uneven Skin Tone - Change From Baseline to Week 24 [Baseline to Week 24]

    3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

20. Mottled Hyperpigmentation - Change From Baseline to Week 1 [Baseline to Week 1]

    3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

21. Mottled Hyperpigmentation - Change From Baseline to Week 4 [Baseline to Week 4]

    3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

22. Mottled Hyperpigmentation - Change From Baseline to Week 12 [Baseline to Week 12]

    3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

23. Mottled Hyperpigmentation - Change From Baseline to Week 24 [Baseline to Week 24]

    3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

24. Sallowness/Yellowing - Change From Baseline to Week 1 [Baseline to Week 1]

    3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

25. Sallowness/Yellowing - Change From Baseline to Week 4 [Baseline to Week 4]

    3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

26. Sallowness/Yellowing - Change From Baseline to Week 12 [Baseline to Week 12]

    3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

27. Sallowness/Yellowing - Change From Baseline to Week 24 [Baseline to Week 24]

    3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

28. Lack of Radiance - Change From Baseline to Week 1 [Baseline to Week 1]

    3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.

29. Lack of Radiance - Change From Baseline to Week 4 [Baseline to Week 4]

    3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.

30. Lack of Radiance - Change From Baseline to Week 12 [Baseline to Week 12]

    3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.

31. Lack of Radiance - Change From Baseline to Week 24 [Baseline to Week 24]

    3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has mild to moderate brown spots

• Has moderate to severe facial wrinkling

• Able to read, write, speak, and understand English

• In general good health

• If capable of having a child: must agree to practice a medically acceptable form of birth control.

• Intends to complete the study and willing to follow all study directions.

Exclusion Criteria:

• Allergies/sensitivity to skincare products or the test product ingredients

• Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results.

• Is taking medication that may cause skin sensitivity to light

• Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results

• Has a facial skin condition (e.g. rosacea, acne, eczema, etc.) that could increase health risk to the subject or confuse the study results.

• Has skin cancer or a history of skin cancer.

• Has an immune deficiency disorder, active hepatitis, or an autoimmune disease.

• Has an uncontrolled metabolic condition (e.g. diabetes, hypertension)

• Is pregnant, nursing, or planning to become pregnant.

• Plans to start or change a hormone replacement therapy during the study.

• Has participated in another study in the past 30 days or plans to during the study.

• Is an employee or relative of the Study Site, Investigator, or Sponsor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	KGL Skin Study Center, LLC	Broomall	Pennsylvania	United States	19008

Sponsors and Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

• Principal Investigator: Stuart Lessin, M.D., KGL Skin Study Center, LLC

Study Documents (Full-Text)

• Study Protocol - Sep 26, 2017
• Statistical Analysis Plan - May 23, 2018

More Information

Publications

• Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402.
• Fitzpatrick RE. Laser resurfacing of rhytides. Dermatol Clin. 1997 Jul;15(3):431-47. Review.
• Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the assessment of cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-51.
• Kim JW. Clinical trial of nonthermal 633 nm Omnilux LED array for renewal of photoaging: clinical surface profile metric results. Korea Soc Las Med Surg. 2005; 9:69-76.
• McCullough JL, Kelly KM. Prevention and treatment of skin aging. Ann N Y Acad Sci. 2006 May;1067:323-31. Review.
• Weiss RA, McDaniel DH, Geronemus RG. Review of nonablative photorejuvenation: reversal of the aging effects of the sun and environmental damage using laser and light sources. Semin Cutan Med Surg. 2003 Jun;22(2):93-106. Review.

• Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
• ClinicalTrials.gov Identifier: NCT03312543
• Other Study ID Numbers: CO-170511132943-SACT
• First Posted: Oct 17, 2017
• Last Update Posted: Mar 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Johnson & Johnson Consumer Inc. (J&JCI): Photoaging of Skin, Skin Wrinkling, Solar Aging of Skin, light therapy

Study Results

Participant Flow

Pre-assignment Detail	At Visit 1 (Screening), participants were enrolled in the study and randomized to the active cell or the sham cell (stratified by skin type). All participants received the same facial cleanser and moisturizer with SPF to use between Visit 1 and Visit 2, and then received the assigned test product (Active Mask or Sham Mask) at Visit 2 (Baseline).

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Period Title: Before Treatment (Screening to Baseline)
STARTED	61	63
COMPLETED	60	59
NOT COMPLETED	1	4
Period Title: Before Treatment (Screening to Baseline)
STARTED	60	59
COMPLETED	56	54
NOT COMPLETED	4	5
Period Title: Before Treatment (Screening to Baseline)
STARTED	56	54
COMPLETED	55	52
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask	Total
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	Total of all reporting groups
Overall Participants	61	63	124
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	56.3 (8.02)	56.6 (7.34)	56.5 (7.65)
Sex: Female, Male (Count of Participants)
Female	61 100%	63 100%	124 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1.6%	1 1.6%	2 1.6%
Not Hispanic or Latino	60 98.4%	62 98.4%	122 98.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 24.6%	18 28.6%	33 26.6%
White	45 73.8%	45 71.4%	90 72.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 1.6%	0 0%	1 0.8%
Fitzpatrick Skin Type (Count of Participants)
I	11 18%	11 17.5%	22 17.7%
II	11 18%	11 17.5%	22 17.7%
III	9 14.8%	11 17.5%	20 16.1%
IV	10 16.4%	11 17.5%	21 16.9%
V	10 16.4%	9 14.3%	19 15.3%
VI	10 16.4%	10 15.9%	20 16.1%
Skin Oiliness Level (Count of Participants)
Oily	2 3.3%	4 6.3%	6 4.8%
Dry	9 14.8%	13 20.6%	22 17.7%
Normal	23 37.7%	17 27%	40 32.3%
Combination	27 44.3%	29 46%	56 45.2%

Outcome Measures

1. Primary Outcome

Title	Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores
Description	3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a scale]	0.18 (0.328)	0.30 (0.341)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.18
	Confidence Interval	(2-Sided) 95%; 0.09 to 0.26
	Parameter Dispersion	Type: Standard Deviation; Value: 0.328
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Active Cell: Active Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.39
	Parameter Dispersion	Type: Standard Deviation; Value: 0.341
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask, Active Cell: Active Mask
	Comments
	Type of Statistical Test	Other
	Comments	The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis	p-Value	0.025
	Comments
	Method	ANCOVA
	Comments	With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.14
	Confidence Interval	(2-Sided) 95%; 0.02 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.060
	Estimation Comments

2. Primary Outcome

Title	Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1
Description	Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a scale.]	0.20 (0.349)	0.22 (0.328)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 95%; 0.11 to 0.29
	Parameter Dispersion	Type: Standard Deviation; Value: 0.349
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Active Cell: Active Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; 0.13 to 0.31
	Parameter Dispersion	Type: Standard Deviation; Value: 0.328
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask, Active Cell: Active Mask
	Comments
	Type of Statistical Test	Equivalence
	Comments	The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis	p-Value	0.540
	Comments
	Method	ANCOVA
	Comments	With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.09 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.062
	Estimation Comments

3. Primary Outcome

Title	Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2
Description	Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a scale.]	-0.03 (0.532)	0.21 (0.500)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	0.627
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.17 to 0.10
	Parameter Dispersion	Type: Standard Deviation; Value: 0.532
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Active Cell: Active Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.21
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.34
	Parameter Dispersion	Type: Standard Deviation; Value: 0.500
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask, Active Cell: Active Mask
	Comments
	Type of Statistical Test	Equivalence
	Comments	The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments	With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.24
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.092
	Estimation Comments

4. Primary Outcome

Title	Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3
Description	Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a scale.]	0.36 (0.465)	0.47 (0.578)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.36
	Confidence Interval	(2-Sided) 95%; 0.23 to 0.48
	Parameter Dispersion	Type: Standard Deviation; Value: 0.465
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Active Cell: Active Mask
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.47
	Confidence Interval	(2-Sided) 95%; 0.32 to 0.63
	Parameter Dispersion	Type: Standard Deviation; Value: 0.578
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sham Cell: Sham Mask, Active Cell: Active Mask
	Comments
	Type of Statistical Test	Equivalence
	Comments	The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.
Statistical Test of Hypothesis	p-Value	0.224
	Comments
	Method	ANCOVA
	Comments	With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 95%; -0.07 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.094
	Estimation Comments

5. Secondary Outcome

Title	Global Wrinkling - Change From Baseline to Week 1
Description	3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a scale]	0.03 (0.158)	0.04 (0.157)

6. Secondary Outcome

Title	Global Wrinkling - Change From Baseline to Week 4
Description	3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a scale]	0.09 (0.208)	0.09 (0.198)

7. Secondary Outcome

Title	Global Wrinkling - Change From Baseline to Week 24
Description	3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a scale]	0.24 (0.410)	0.30 (0.378)

8. Secondary Outcome

Title	Fine Lines - Change From Baseline to Week 1
Description	3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a scale]	0.01 (0.132)	0.05 (0.160)

9. Secondary Outcome

Title	Fine Lines - Change From Baseline to Week 4
Description	3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	0.08 (0.196)	0.13 (0.205)

10. Secondary Outcome

Title	Fine Lines - Change From Baseline to Week 12
Description	3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	54
Mean (Standard Deviation) [Units on a Scale]	0.23 (0.309)	0.32 (0.358)

11. Secondary Outcome

Title	Fine Lines - Change From Baseline to Week 24
Description	3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a Scale]	0.28 (0.358)	0.29 (0.349)

12. Secondary Outcome

Title	Periorbital Wrinkles - Change From Baseline to Week 1
Description	3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a Scale]	0.00 (0.176)	0.01 (0.172)

13. Secondary Outcome

Title	Periorbital Wrinkles - Change From Baseline to Week 4
Description	3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	0.10 (0.269)	0.10 (0.246)

14. Secondary Outcome

Title	Periorbital Wrinkles - Change From Baseline to Week 12
Description	3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	64
Mean (Standard Deviation) [Units on a Scale]	0.15 (0.355)	0.30 (0.366)

15. Secondary Outcome

Title	Periorbital Wrinkles - Change From Baseline to Week 24
Description	3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a Scale]	0.22 (0.399)	0.29 (0.401)

16. Secondary Outcome

Title	Surface Roughness - Change From Baseline to Week 1
Description	3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a Scale]	0.35 (0.396)	0.38 (0.386)

17. Secondary Outcome

Title	Surface Roughness - Change From Baseline to Week 4
Description	3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	0.79 (0.438)	0.76 (0.520)

18. Secondary Outcome

Title	Surface Roughness - Change From Baseline to Week 12
Description	3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	54
Mean (Standard Deviation) [Units on a Scale]	0.94 (0.449)	0.89 (0.576)

19. Secondary Outcome

Title	Surface Roughness - Change From Baseline to Week 24
Description	3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a Scale]	1.12 (0.549)	0.95 (0.686)

20. Secondary Outcome

Title	Uneven Skin Tone - Change From Baseline to Week 1
Description	3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a Scale]	0.04 (0.176)	0.06 (0.119)

21. Secondary Outcome

Title	Uneven Skin Tone - Change From Baseline to Week 4
Description	3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	0.18 (0.282)	0.23 (0.287)

22. Secondary Outcome

Title	Uneven Skin Tone - Change From Baseline to Week 12
Description	3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	54
Mean (Standard Deviation) [Units on a Scale]	0.36 (0.388)	0.49 (0.487)

23. Secondary Outcome

Title	Uneven Skin Tone - Change From Baseline to Week 24
Description	3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a Scale]	0.44 (0.378)	0.52 (0.499)

24. Secondary Outcome

Title	Mottled Hyperpigmentation - Change From Baseline to Week 1
Description	3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a Scale]	-0.01 (0.166)	-0.02 (0.174)

25. Secondary Outcome

Title	Mottled Hyperpigmentation - Change From Baseline to Week 4
Description	3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	0.10 (0.313)	0.15 (0.288)

26. Secondary Outcome

Title	Mottled Hyperpigmentation - Change From Baseline to Week 12
Description	3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	54
Mean (Standard Deviation) [Units on a Scale]	0.22 (0.456)	0.39 (0.392)

27. Secondary Outcome

Title	Mottled Hyperpigmentation - Change From Baseline to Week 24
Description	3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a Scale]	0.25 (0.467)	0.31 (0.401)

28. Secondary Outcome

Title	Sallowness/Yellowing - Change From Baseline to Week 1
Description	3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a Scale]	-0.01 (0.276)	0.01 (0.179)

29. Secondary Outcome

Title	Sallowness/Yellowing - Change From Baseline to Week 4
Description	3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	0.12 (0.247)	0.12 (0.354)

30. Secondary Outcome

Title	Sallowness/Yellowing - Change From Baseline to Week 12
Description	3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	54
Mean (Standard Deviation) [Units on a Scale]	0.23 (0.390)	0.33 (0.496)

31. Secondary Outcome

Title	Sallowness/Yellowing - Change From Baseline to Week 24
Description	3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a Scale]	0.29 (0.445)	0.32 (0.504)

32. Secondary Outcome

Title	Lack of Radiance - Change From Baseline to Week 1
Description	3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	59	57
Mean (Standard Deviation) [Units on a Scale]	0.07 (0.219)	0.13 (0.258)

33. Secondary Outcome

Title	Lack of Radiance - Change From Baseline to Week 4
Description	3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 4

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	56
Mean (Standard Deviation) [Units on a Scale]	0.28 (0.357)	0.37 (0.401)

34. Secondary Outcome

Title	Lack of Radiance - Change From Baseline to Week 12
Description	3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	56	54
Mean (Standard Deviation) [Units on a Scale]	0.41 (0.412)	0.55 (0.493)

35. Secondary Outcome

Title	Lack of Radiance - Change From Baseline to Week 24
Description	3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.
Time Frame	Baseline to Week 24

Outcome Measure Data

Analysis Population Description

Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Sham Cell: Sham Mask	Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
Measure Participants	55	52
Mean (Standard Deviation) [Units on a Scale]	0.54 (0.454)	0.59 (0.517)

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 24 unless terminated early). Serious adverse events (SAE) reported to the site were also reportable within 30 days of last procedure/visit and longer if considered study-related; there was no specific cut-off date for this reporting, but AEs/SAEs are shown in this posting for a collection period of approximately 6 months from last subject's visit (the time of this posting).
Adverse Event Reporting Description	The Investigator or a designee interviewed subjects for changes in health/medication at each visit, documenting any reported adverse events. The analysis population is all randomized subjects who used the investigational device (i.e. the subjects enrolled in the treatment period).
Arm/Group Title	Sham Cell: Sham Mask		Active Cell: Active Mask
Arm/Group Description	A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the sham light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.		A facial cleanser was used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF was applied full-face. For the first 12 weeks of the study, the active light therapy mask was used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage was discontinued.
All Cause Mortality
	Sham Cell: Sham Mask		Active Cell: Active Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		1/59 (1.7%)
Serious Adverse Events
	Sham Cell: Sham Mask		Active Cell: Active Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		1/59 (1.7%)
General disorders
Sudden Death	0/60 (0%)	0	1/59 (1.7%)	1
Other (Not Including Serious) Adverse Events
	Sham Cell: Sham Mask		Active Cell: Active Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/60 (6.7%)		5/59 (8.5%)
Infections and infestations
Upper Respiratory Tract Infection	1/60 (1.7%)	1	5/59 (8.5%)	5
Oral Herpes	3/60 (5%)	3	0/59 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI must provide Sponsor 60 days to review any publication (unless expedited review requested); if it includes Sponsor's confidential info, written Sponsor approval is required. Sponsor may require another 60 days' delay to file a patent application.