Safety and Efficacy of the Luxe Device to Treat Facial Wrinkles and Rosacea

• Sponsor: Syneron Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01618864
• Collaborator: (none)
• Enrollment: 23
• Locations: 2
• Arm: 1
• Duration (Months): 9
• Patients Per Site: 11.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This study is designed to evaluate the efficacy and safety of the Luxe™ device for use in wrinkle and rosacea treatment.

Up to 60 subjects will treat their periorbital and cheek areas daily for 4 weeks and then twice a week for an additional 4 weeks. Evaluations of improvement will be conducted at the clinic after enrollment and during the treatment at 1, 2, 4, and 8 weeks after initiation.

Condition or Disease	Intervention/Treatment	Phase
Rosacea; Wrinkles	Device: Luxe	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy Evaluation of the Luxe™ Device for the Treatment of Facial Wrinkles and Rosacea
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Luxe	Device: Luxe; Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.

Outcome Measures

Primary Outcome Measures

1. Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI) [4, 8 weeks]

   Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.

Secondary Outcome Measures

1. Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale [4, 8 weeks]

   Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.

2. Reduction in Rosacea by the Study Investigator Using a Validated Scale [4, 8 weeks]

   Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy male or female between the ages of 21 and 60.

2. Non-smoker.

3. Have no prior experience with the Luxe™ device.

4. Having wrinkles, rhytides and fine lines in periorbital regions that are classified as wrinkle type 1-3 on the Crow's Feet Grading Scale and/or having rosacea cheeks regions.

5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.

6. Agree to make no changes in their existing skin-care regime, other than use of the study products, during the study period.

7. Able to understand and provide written Informed Consent.

8. Women of child-bearing age should pass a negative pregnancy test, and required to be using a reliable method of birth control at least 3 months prior to and throughout study enrollment.

Exclusion Criteria:

1. Fail to meet any of the inclusion criteria above.

2. Subject unable or unwilling to provide proper informed consent for participation.

3. Subject not able to understand the requirements of the study.

4. Pregnant or nursing women or intending to become pregnant during the course of study.

5. Reported having one of the following medical conditions that could result in potential harm to themselves or other:

• Obvious cognitive deficit.

• Neuromotor control difficulty with either hand.

• Sensitivity to light.

• History of light activated medical problems such as light triggered seizure disorders or migraine headaches.

• Taking drugs which may cause light sensitivity.

1. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.

2. Having a permanent implant in the treated area, such as metal plates and screws

3. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study.

4. Prior or current skin therapy that may interfere with the evaluation of the study device: Renova, AHAs, Vitamin C, Kinerase, Tretinoin, Topical Retinoids, Topical Steroids, Antibiotics (topical or oral) within 14 days of baseline visit.

Oral Retinoids within 6 month of baseline visit.

1. Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment or during the course of the study.

2. Subject currently being treated for a dermatologic condition which may interfere with the safe evaluation of the study device (Eczema, Psoriasis, Severe sun damage, Dermatitis).

3. Patient on systemic corticosteroid therapy 6 months prior to and throughout the course of the study.

4. Subject with a history of hypersensitivity or allergy to (LED) light.

5. Subject with a history of hypersensitivity or allergy to any formulation or device component.

6. Having received a facial dermabrasion or chemical peel treatment within 3 months of treatment or during the study.

7. Prior skin treatment with laser in treated area within 3 months of initial treatment or during the course of the study.

8. Prior use of Botox, collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 2 month of initial treatment or during the course of the study. Treatment may not be performed, at all, over permanent dermal implants.

9. Prior ablative resurfacing procedure, brow lift, blepharoplasty or face lift in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.

10. Any other surgery in treated area within 12 months of initial treatment or during the course of the study.

11. History of keloid formation or poor wound healing in a previously injured skin area.

12. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).

13. Open laceration or abrasion of any sort on the area to be treated.

14. Active Herpes Simplex I at the time of treatment.

15. Multiple dysplastic nevi in the area to be treated.

16. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to the treatment (as per the subject's physician discretion).

17. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.

18. Having any form of active cancer (especially skin cancer: BCC, SCC, and Melanoma) at the time of enrollment and during the course of the study.

19. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the investigator would interfere with the treatment, or healing process.

20. Subjects who have initiated treatment with hormones including estrogen, progesterone, or oral contraceptives for 12 weeks or less, immediately preceding study entry, who intend to discontinue hormonal therapy during the study.

21. Participation in a study of another device or drug within 1 month prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria.

22. Subjects with history of past or present drug/ alcohol abuse.

23. Mentally incompetent, prisoner or evidence of active substance.

24. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Laser & Skin Care	New York	New York	United States	10028
2	Sadick Dermatology	New York	New York	United States	10075

Sponsors and Collaborators

• Syneron Medical

Investigators

• Principal Investigator: Neil Sadick, MD, Sadick Dermatology
• Principal Investigator: Arielle NB Kauvar, MD, New York Laser & Skin Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Syneron Medical
• ClinicalTrials.gov Identifier: NCT01618864
• Other Study ID Numbers: Luxe01
• First Posted: Jun 13, 2012
• Last Update Posted: Aug 11, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Rosacea

Study Results

Participant Flow

Arm/Group Title	Luxe Treatment Group
Arm/Group Description	Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
Period Title: Overall Study
STARTED	23
Completed 2 Weeks	19
COMPLETED	19
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Luxe Treatment Group
Arm/Group Description	Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	22 95.7%
>=65 years	1 4.3%
Sex: Female, Male (Count of Participants)
Female	19 82.6%
Male	4 17.4%
Region of Enrollment (participants) [Number]
United States	23 100%

Outcome Measures

1. Primary Outcome

Title	Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)
Description	Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.
Time Frame	4, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Luxe Treatment Group at 4 Weeks	Luxe Treatment Group at 8 Weeks
Arm/Group Description	Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.	GAI assessment by investigator at 8 weeks.
Measure Participants	19	19
Number [percentage of participants]	61 265.2%	68 NaN

2. Secondary Outcome

Title	Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale
Description	Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.
Time Frame	4, 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Luxe Treatment Group at 4 Weeks	Luxe Treatment Group at 8 Weeks
Arm/Group Description	Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by assessment.	Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks and assessment at week 8.
Measure Participants	19	19
Number [percentage of participants]	68 295.7%	68 NaN

3. Secondary Outcome

Title	Reduction in Rosacea by the Study Investigator Using a Validated Scale
Description	Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.
Time Frame	4, 8 weeks

Outcome Measure Data

Analysis Population Description

Not all subjects had rosacea. 11 subjects evaluated at baseline and 4 weeks; 9 subjects evaluated at 8 weeks, since 2 subjects lost to follow-up.

Arm/Group Title	Luxe Treatment Group at 4 Weeks	Luxe Treatment Group at 8 Weeks
Arm/Group Description	Subjects with rosacea were evaluated by the investigator and a score provided according to a validated rosacea scale for improvement in features of rosacea such as flushing.	Evaluation of rosacea after 8 weeks of treatment.
Measure Participants	11	9
Number [percentage of participants]	64 278.3%	89 NaN

Adverse Events

Time Frame	Adverse event data collected during 8 weeks of treatment.
Arm/Group Title	Treatment Group
Arm/Group Description	All treated subjects were evaluated for adverse events during the study.
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/23 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	2/23 (8.7%)
Skin and subcutaneous tissue disorders
Acne	2/23 (8.7%)	2

Limitations/Caveats

Small number of subjects analyzed for post-marketing study.

More Information

Certain Agreements

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

Sponsor reserves the right to remove all Confidential Information from any publications or presentations to protect its intellectual property rights.