A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03124381
• Collaborator: (none)
• Enrollment: 126
• Locations: 2
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site: 63
• Patients Per Site Per Month: 12.7

Study Details

Study Description

Brief Summary

This study will compare two different acne treatment regimens for the treatment of acne. Half of participants will receive a cleanser and a light therapy mask, while half of the participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy mask.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Device: Cleanser, Acne Mask; Device: Cleanser, Gel-Cream, Acne Mask	N/A

Detailed Description

Acne vulgaris is a common chronic skin disease involving blockage and/or inflammation of the hair follicles and their accompany sebaceous glands.

Research has shown the benefits of red and blue light therapy in the treatment of mild to moderate acne, with red and blue light shown to target acne-causing bacteria and have an effect on inflammation reduction.

Light-based therapies have been used successfully to treat dermatological conditions since the early 1900s, with various parts of the electromagnetic spectrum (i.e. ultraviolet [UV], visible, near-infrared, etc.) demonstrating different benefits. Light-emitting diodes (LEDs) offer delivery of light to the skin in a gentler manner as compared to light delivered by lasers, primarily due to the lower energy output. It has been reported that LEDs do not deliver enough power to damage tissues and do not have the same risk of accidental eye damage that lasers do. Visible-LED light therapy has been deemed a non-significant risk by the U.S. Food and Drug Administration (FDA) and has been approved for use in humans.

It is well established in the literature that visible light penetration into the epidermal and dermal layers of human skin is primarily governed by absorption and scattering events, with the latter being the more impactful of the two. Visible light penetration into human skin can be increased by reducing scattering. This can be accomplished by temporary hydrogen bonding disruption, which leads to the reversible rearrangement of epidermal and dermal structures that cause scattering. Glycerol (i.e. glycerin) is hypothesized to generate the level of hydrogen bonding disruption described above, and therefore will be investigated in the present study.

This study will look to evaluate and then compare the acne clearing efficacy and tolerance of two different acne treatment regimens - a cleanser used with a currently marketed red and blue light acne light therapy mask alone vs. the cleanser used with the same mask in conjunction with a light therapy topical gel-cream - to determine the efficacy of these treatments and then to assess if the efficacy of the light therapy mask used with the topical gel-cream treatment is non-inferior to the mask alone in the reduction of lesions in mild to moderate acne. If non-inferiority is demonstrated, the mask with topical gel-cream treatment will be further assessed for its superiority to the mask alone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Evaluator-blind
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Evaluator Blinded, Randomized Clinical Study to Evaluate the Efficacy and Tolerance of Two Acne Treatment Regimens on Subjects With Mild to Moderate Acne Vulgaris
• Actual Study Start Date: Apr 8, 2017
• Actual Primary Completion Date: Sep 6, 2017
• Actual Study Completion Date: Sep 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acne Mask Cleanser, Acne Mask	Device: Cleanser, Acne Mask; A facial cleanser will be used twice daily (morning and evening). The light therapy mask will be used for 10 minutes in the evening after washing/drying the face.; Other Names: Light Therapy Mask
Experimental: Gel-Cream + Acne Mask Cleanser, Gel-Cream, Acne Mask	Device: Cleanser, Gel-Cream, Acne Mask; A facial cleanser will be used twice daily (morning and evening). In the evening after cleansing, the gel-cream will be applied full face and allowed to dry before the light therapy mask is used for 10 minutes.; Other Names: Light Therapy Mask Light Therapy Topical Gel-Cream

Outcome Measures

Primary Outcome Measures

1. Global Face Total Lesion Count - Percent Change - Baseline to Week 12 [Baseline and Week 12]

   Percent change from baseline in global face total lesion count at Week 12

Secondary Outcome Measures

1. Global Face Total Lesion Count - Percent Change - Baseline to Week 2 [Baseline and Week 2]

   Percent change from baseline in global face total lesion count at Week 2

2. Global Face Total Lesion Count - Percent Change - Baseline to Week 4 [Baseline and Week 4]

   Percent change from baseline in global face total lesion count at Week 4

3. Global Face Total Lesion Count - Percent Change - Baseline to Week 8 [Baseline and Week 8]

   Percent change from baseline in global face total lesion count at Week 8

4. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits [Baseline to Week 2, Week 4, Week 8, and Week 12]

   Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated.

5. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4 [Baseline to Week 2 and Week 4]

   Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.

6. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8 [Baseline to Week 4 and Week 8]

   Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.

7. Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12 [Baseline to Week 8 and Week 12]

   Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.

8. Global Face Open Comedones Count - Week 2 [2 weeks]

   Open comedones count on global face - Week 2

9. Global Face Open Comedones Count - Week 4 [4 weeks]

   Open comedones count on global face - Week 4

10. Global Face Open Comedones Count - Week 8 [8 weeks]

    Open comedones count on global face - Week 8

11. Global Face Open Comedones Count - Week 12 [12 weeks]

    Open comedones count on global face - Week 12

12. Global Face Closed Comedones Count - Week 2 [2 weeks]

    Closed comedones count on global face - Week 2

13. Global Face Closed Comedones Count - Week 4 [4 weeks]

    Closed comedones count on global face - Week 4

14. Global Face Closed Comedones Count - Week 8 [8 weeks]

    Closed comedones count on global face - Week 8

15. Global Face Closed Comedones Count - Week 12 [12 weeks]

    Closed comedones count on global face - Week 12

16. Global Face Inflammatory Lesion Count - Week 2 [2 weeks]

    Papules and pustules counted together

17. Global Face Inflammatory Lesion Count - Week 4 [4 weeks]

    Papules and pustules counted together

18. Global Face Inflammatory Lesion Count - Week 8 [8 weeks]

    Papules and pustules counted together

19. Global Face Inflammatory Lesion Count - Week 12 [12 weeks]

    Papules and pustules counted together

20. Global Face Non-Inflammatory Lesion Count - Week 2 [2 weeks]

    Sum of open comedones and closed comedones

21. Global Face Non-Inflammatory Lesion Count - Week 4 [4 weeks]

    Sum of open comedones and closed comedones

22. Global Face Non-Inflammatory Lesion Count - Week 8 [8 weeks]

    Sum of open comedones and closed comedones

23. Global Face Non-Inflammatory Lesion Count - Week 12 [12 weeks]

    Sum of open comedones and closed comedones

24. Global Face Total Lesion Count - Week 2 [2 weeks]

    Sum of inflammatory and non-inflammatory lesions

25. Global Face Total Lesion Count - Week 4 [4 weeks]

    Sum of inflammatory and non-inflammatory lesions

26. Global Face Total Lesion Count - Week 8 [8 weeks]

    Sum of inflammatory and non-inflammatory lesions

27. Global Face Total Lesion Count - Week 12 [12 weeks]

    Sum of inflammatory and non-inflammatory lesions

28. Investigator Global Acne Assessment - Week 1 [1 week]

    Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.

29. Investigator Global Acne Assessment - Week 2 [2 weeks]

    Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.

30. Investigator Global Acne Assessment - Week 4 [4 weeks]

    Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.

31. Investigator Global Acne Assessment - Week 8 [8 weeks]

    Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.

32. Investigator Global Acne Assessment - Week 12 [12 weeks]

    Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.

33. Overall Redness of Inflammatory Lesions - Week 1 [1 week]

    Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness

34. Overall Redness of Inflammatory Lesions - Week 2 [2 weeks]

    Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness

35. Overall Redness of Inflammatory Lesions - Week 4 [4 weeks]

    Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness

36. Overall Redness of Inflammatory Lesions - Week 8 [8 weeks]

    Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness

37. Overall Redness of Inflammatory Lesions - Week 12 [12 weeks]

    Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness

38. Overall Size of Inflammatory Lesions - Week 1 [1 week]

    Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large

39. Overall Size of Inflammatory Lesions - Week 2 [2 weeks]

    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large

40. Overall Size of Inflammatory Lesions - Week 4 [4 weeks]

    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large

41. Overall Size of Inflammatory Lesions - Week 8 [8 weeks]

    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.

42. Overall Size of Inflammatory Lesions - Week 12 [12 weeks]

    Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has mild to moderate facial acne

• Has 10-100 blackheads/whiteheads, 10-50 pimples, no cysts, and up to 2 large, hard, painful bumps (nodules)

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

• In general good health

• Must agree to practice a medically acceptable form of birth control.

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

Exclusion Criteria:

• Very sensitive skin or 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 using medication that makes skin more sensitive to light

• Has severe acne or a pre-existing facial skin condition other than mild to moderate acne

• has an immune deficiency disorder

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

• Females that are pregnant, nursing, or planning to become pregnant

• Males with a female partner who is pregnant or planning to become pregnant

• Has excessive facial hair

• Is participating in another study within past 4 weeks

• Is related to the Sponsor, Investigator, or Study Site

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academic Dermatology Associates	Albuquerque	New Mexico	United States	87106
2	Thomas J. Stephens and Associates, Inc.	Richardson	Texas	United States	75081

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Alicia Bucko, D.O., Academic Dermatology Associates
• Principal Investigator: Lily Jiang, Ph.D., Thomas J. Stephens & Associates, Inc.

Study Documents (Full-Text)

• Statistical Analysis Plan - Oct 19, 2017
• Study Protocol - Mar 6, 2017

More Information

Publications

• Ashkenazi H, Malik Z, Harth Y, Nitzan Y. Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light. FEMS Immunol Med Microbiol. 2003 Jan 21;35(1):17-24.
• Barolet D. Light-emitting diodes (LEDs) in dermatology. Semin Cutan Med Surg. 2008 Dec;27(4):227-38. doi: 10.1016/j.sder.2008.08.003. Review.
• Bashkatov, AN, et al. Optical properties of human skin, subcutaneous and mucous tissues in the wavelength range from 400 to 2000 nm. J Phys D: Appl Phys, 38: 2543-2555, 2005.
• Bashkatov, AN, et al. Optical properties of melanin in the skin and skin-like phantoms. Proc. of SPIE, 4162: 219-226, 2000.
• Hirshburg J, Choi B, Nelson JS, Yeh AT. Correlation between collagen solubility and skin optical clearing using sugars. Lasers Surg Med. 2007 Feb;39(2):140-4.
• Jacques SL. Optical properties of biological tissues: a review. Phys Med Biol. 2013 Jun 7;58(11):R37-61. doi: 10.1088/0031-9155/58/11/R37. Epub 2013 May 10. Review. Erratum in: Phys Med Biol. 2013 Jul 21;58(14):5007-8.
• Kjeldstad B. Photoinactivation of Propionibacterium acnes by near-ultraviolet light. Z Naturforsch C Biosci. 1984 Mar-Apr;39(3-4):300-2.
• Lamouche G, Kennedy BF, Kennedy KM, Bisaillon CE, Curatolo A, Campbell G, Pazos V, Sampson DD. Review of tissue simulating phantoms with controllable optical, mechanical and structural properties for use in optical coherence tomography. Biomed Opt Express. 2012 Jun 1;3(6):1381-98. doi: 10.1364/BOE.3.001381. Epub 2012 May 15.
• Pogue BW, Patterson MS. Review of tissue simulating phantoms for optical spectroscopy, imaging and dosimetry. J Biomed Opt. 2006 Jul-Aug;11(4):041102. Review.
• Roelandts R. A new light on Niels Finsen, a century after his Nobel Prize. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):115-7.
• Salomatina E, Jiang B, Novak J, Yaroslavsky AN. Optical properties of normal and cancerous human skin in the visible and near-infrared spectral range. J Biomed Opt. 2006 Nov-Dec;11(6):064026.
• Wiegand, B, Luedtke, K, Rapp, SR. Acne Profile. Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003, assignee. Patent US 2006/0008484 A1. 12 Jan. 2006. Print.

• Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
• ClinicalTrials.gov Identifier: NCT03124381
• Other Study ID Numbers: PS-170103145529-SACT
• First Posted: Apr 21, 2017
• Last Update Posted: Feb 15, 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): Acne
• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Period Title: Overall Study
STARTED	65	61
COMPLETED	56	55
NOT COMPLETED	9	6

Baseline Characteristics

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask	Total
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask	Total of all reporting groups
Overall Participants	65	61	126
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	18.8 (6.03)	20.0 (7.65)	19.4 (6.86)
Sex: Female, Male (Count of Participants)
Female	38 58.5%	32 52.5%	70 55.6%
Male	27 41.5%	29 47.5%	56 44.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	25 38.5%	23 37.7%	48 38.1%
Not Hispanic or Latino	40 61.5%	38 62.3%	78 61.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.5%	1 1.6%	2 1.6%
Asian	3 4.6%	1 1.6%	4 3.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	12 18.5%	10 16.4%	22 17.5%
White	47 72.3%	47 77%	94 74.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 3.1%	2 3.3%	4 3.2%
Skin Sensitivity (Count of Participants)
None of the Time	38 58.5%	40 65.6%	78 61.9%
Some of the Time	21 32.3%	18 29.5%	39 31%
Most of the Time	6 9.2%	1 1.6%	7 5.6%
All of the Time	0 0%	2 3.3%	2 1.6%
Fitzpatrick Skin Type (Count of Participants)
I	0 0%	0 0%	0 0%
II	24 36.9%	28 45.9%	52 41.3%
III	18 27.7%	14 23%	32 25.4%
IV	12 18.5%	10 16.4%	22 17.5%
V	10 15.4%	6 9.8%	16 12.7%
VI	1 1.5%	3 4.9%	4 3.2%

Outcome Measures

1. Primary Outcome

Title	Global Face Total Lesion Count - Percent Change - Baseline to Week 12
Description	Percent change from baseline in global face total lesion count at Week 12
Time Frame	Baseline and 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. There was no post-baseline data to carry forward for three subjects.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Percent Change in Lesions]	-42.64 (31.817)	-47.80 (30.209)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gel-Cream + Acne Mask, Acne Mask
	Comments	Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.19
	Confidence Interval	(2-Sided) 95%; -7.04 to 13.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.164
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Gel-Cream + Acne Mask, Acne Mask
	Comments	Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A-B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.
	Type of Statistical Test	Superiority
	Comments	Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.
Statistical Test of Hypothesis	p-Value	0.538
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.19
	Confidence Interval	(2-Sided) 95%; -7.04 to 13.42
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.164
	Estimation Comments

2. Secondary Outcome

Title	Global Face Total Lesion Count - Percent Change - Baseline to Week 2
Description	Percent change from baseline in global face total lesion count at Week 2
Time Frame	Baseline and Week 2

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Percent Change in Lesions]	-24.16 (25.646)	-27.97 (21.330)

3. Secondary Outcome

Title	Global Face Total Lesion Count - Percent Change - Baseline to Week 4
Description	Percent change from baseline in global face total lesion count at Week 4
Time Frame	Baseline and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Percent Change in Lesions]	-29.78 (27.388)	-38.25 (22.729)

4. Secondary Outcome

Title	Global Face Total Lesion Count - Percent Change - Baseline to Week 8
Description	Percent change from baseline in global face total lesion count at Week 8
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Percent Change in Lesions]	-39.81 (26.192)	-45.86 (23.369)

5. Secondary Outcome

Title	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits
Description	Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated.
Time Frame	Baseline to Week 2, Week 4, Week 8, and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Percent Change in Lesions]	-33.68 (24.212)	-39.79 (20.754)

6. Secondary Outcome

Title	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4
Description	Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.
Time Frame	Baseline to Week 2 and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Percent Change in Lesions]	-26.95 (24.419)	-33.01 (19.648)

7. Secondary Outcome

Title	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8
Description	Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.
Time Frame	Baseline to Week 4 and Week 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Percent Change in Lesions]	-34.34 (25.438)	-42.09 (21.082)

8. Secondary Outcome

Title	Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12
Description	Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.
Time Frame	Baseline to Week 8 and 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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	58	55
Mean (Standard Deviation) [Percent Change in Lesions]	-41.73 (27.472)	-47.25 (46.201)

9. Secondary Outcome

Title	Global Face Open Comedones Count - Week 2
Description	Open comedones count on global face - Week 2
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Open Comedones]	8.1 (10.68)	5.6 (6.41)

10. Secondary Outcome

Title	Global Face Open Comedones Count - Week 4
Description	Open comedones count on global face - Week 4
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Open Comedones]	7.9 (10.37)	5.3 (6.27)

11. Secondary Outcome

Title	Global Face Open Comedones Count - Week 8
Description	Open comedones count on global face - Week 8
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Open Comedones]	5.1 (7.83)	4.5 (6.03)

12. Secondary Outcome

Title	Global Face Open Comedones Count - Week 12
Description	Open comedones count on global face - Week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Open Comedones]	3.6 (5.2)	3.7 (6.31)

13. Secondary Outcome

Title	Global Face Closed Comedones Count - Week 2
Description	Closed comedones count on global face - Week 2
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Closed Comedones]	14.7 (10.66)	12.7 (9.41)

14. Secondary Outcome

Title	Global Face Closed Comedones Count - Week 4
Description	Closed comedones count on global face - Week 4
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Closed Comedones]	14.1 (11.69)	10.9 (7.01)

15. Secondary Outcome

Title	Global Face Closed Comedones Count - Week 8
Description	Closed comedones count on global face - Week 8
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Closed Comedones]	12.7 (10.38)	10.3 (7.05)

16. Secondary Outcome

Title	Global Face Closed Comedones Count - Week 12
Description	Closed comedones count on global face - Week 12
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Closed Comedones]	11.9 (10.01)	10.2 (9.00)

17. Secondary Outcome

Title	Global Face Inflammatory Lesion Count - Week 2
Description	Papules and pustules counted together
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Inflammatory Lesions]	12.1 (8.23)	10.3 (5.24)

18. Secondary Outcome

Title	Global Face Inflammatory Lesion Count - Week 4
Description	Papules and pustules counted together
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Inflammatory Lesions]	10.8 (7.56)	9.1 (6.15)

19. Secondary Outcome

Title	Global Face Inflammatory Lesion Count - Week 8
Description	Papules and pustules counted together
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Inflammatory Lesions]	9.9 (6.85)	7.8 (5.07)

20. Secondary Outcome

Title	Global Face Inflammatory Lesion Count - Week 12
Description	Papules and pustules counted together
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Inflammatory Lesions]	9.7 (7.19)	7.7 (6.44)

21. Secondary Outcome

Title	Global Face Non-Inflammatory Lesion Count - Week 2
Description	Sum of open comedones and closed comedones
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Non-inflammatory Lesions]	22.7 (15.94)	18.3 (11.74)

22. Secondary Outcome

Title	Global Face Non-Inflammatory Lesion Count - Week 4
Description	Sum of open comedones and closed comedones
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Non-inflammatory lesions]	22.0 (16.39)	16.2 (10.51)

23. Secondary Outcome

Title	Global Face Non-Inflammatory Lesion Count - Week 8
Description	Sum of open comedones and closed comedones
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Non-inflammatory Lesions]	17.8 (13.92)	14.8 (10.68)

24. Secondary Outcome

Title	Global Face Non-Inflammatory Lesion Count - Week 12
Description	Sum of open comedones and closed comedones
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Non-inflammatory Lesions]	15.6 (12.92)	14.0 (13.39)

25. Secondary Outcome

Title	Global Face Total Lesion Count - Week 2
Description	Sum of inflammatory and non-inflammatory lesions
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Lesions]	34.8 (19.30)	28.6 (13.10)

26. Secondary Outcome

Title	Global Face Total Lesion Count - Week 4
Description	Sum of inflammatory and non-inflammatory lesions
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Lesions]	32.8 (20.10)	25.2 (13.53)

27. Secondary Outcome

Title	Global Face Total Lesion Count - Week 8
Description	Sum of inflammatory and non-inflammatory lesions
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Lesions]	27.7 (17.41)	22.5 (13.95)

28. Secondary Outcome

Title	Global Face Total Lesion Count - Week 12
Description	Sum of inflammatory and non-inflammatory lesions
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Lesions]	25.3 (17.56)	21.7 (17.58)

29. Secondary Outcome

Title	Investigator Global Acne Assessment - Week 1
Description	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	64	60
Mean (Standard Deviation) [Units on a scale]	2.29 (0.444)	2.27 (0.427)

30. Secondary Outcome

Title	Investigator Global Acne Assessment - Week 2
Description	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Units on a scale]	2.17 (0.500)	2.06 (0.470)

31. Secondary Outcome

Title	Investigator Global Acne Assessment - Week 4
Description	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Units on a scale]	2.00 (0.587)	1.90 (0.583)

32. Secondary Outcome

Title	Investigator Global Acne Assessment - Week 8
Description	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Units on a scale]	1.84 (0.669)	1.73 (0.600)

33. Secondary Outcome

Title	Investigator Global Acne Assessment - Week 12
Description	Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Units on a scale]	1.64 (0.724)	1.64 (0.589)

34. Secondary Outcome

Title	Overall Redness of Inflammatory Lesions - Week 1
Description	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	64	60
Mean (Standard Deviation) [Units on a scale]	4.88 (1.222)	5.05 (1.278)

35. Secondary Outcome

Title	Overall Redness of Inflammatory Lesions - Week 2
Description	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Units on a scale]	4.65 (1.183)	4.74 (1.202)

36. Secondary Outcome

Title	Overall Redness of Inflammatory Lesions - Week 4
Description	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Units on a scale]	4.49 (1.291)	4.41 (1.318)

37. Secondary Outcome

Title	Overall Redness of Inflammatory Lesions - Week 8
Description	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Units on a scale]	4.30 (1.278)	4.25 (1.446)

38. Secondary Outcome

Title	Overall Redness of Inflammatory Lesions - Week 12
Description	Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Units on a scale]	3.96 (1.346)	3.97 (1.282)

39. Secondary Outcome

Title	Overall Size of Inflammatory Lesions - Week 1
Description	Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
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 may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	64	60
Mean (Standard Deviation) [Units on a scale]	4.58 (1.298)	4.83 (1.371)

40. Secondary Outcome

Title	Overall Size of Inflammatory Lesions - Week 2
Description	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	63	60
Mean (Standard Deviation) [Units on a scale]	4.17 (1.129)	4.56 (1.222)

41. Secondary Outcome

Title	Overall Size of Inflammatory Lesions - Week 4
Description	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	62	56
Mean (Standard Deviation) [Units on a scale]	4.07 (1.273)	4.15 (1.408)

42. Secondary Outcome

Title	Overall Size of Inflammatory Lesions - Week 8
Description	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	57	55
Mean (Standard Deviation) [Units on a scale]	3.88 (1.290)	3.85 (1.606)

43. Secondary Outcome

Title	Overall Size of Inflammatory Lesions - Week 12
Description	Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Gel-Cream + Acne Mask	Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask	Cleanser, Acne Mask
Measure Participants	56	55
Mean (Standard Deviation) [Units on a scale]	3.67 (1.305)	3.59 (1.411)

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of informed consent through subject's last study procedure (Week 12 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 1 year 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.
Arm/Group Title	Gel-Cream + Acne Mask		Acne Mask
Arm/Group Description	Cleanser, Gel-Cream, Acne Mask		Cleanser, Acne Mask
All Cause Mortality
	Gel-Cream + Acne Mask		Acne Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/61 (0%)
Serious Adverse Events
	Gel-Cream + Acne Mask		Acne Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	Gel-Cream + Acne Mask		Acne Mask
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/61 (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 includes Sponsor's confidential info, written Sponsor approval is required. Sponsor may require another 60 days' delay to file patent app. If multicenter, PI agrees 1st publication is joint publication. If joint publication not submitted within 24 months of study end or Sponsor confirms there will be no joint publication, PI may publish the results individually following previous guidelines.