Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

Study Overview
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Brief Summary
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To evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer.

Official Title
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A Single Center, Prospective, Blinded Study to Evaluate the Efficacy and Safety of a Tripeptide/Hexapeptide Topical When Used With Er:YAG Hybrid Laser for the Treatment of Acne Scars

Conditions
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Acne Scars - Mixed Atrophic and Hypertrophic

Intervention / Treatment
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* Device: Hybrid fractional laser
* Other: Alastin Regenerating Skin Nectar with TriHex Technology
* Other: Cetaphil face cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or females age 18 and older with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman & Baron qualitative global acne scar grading system Exclusion Criteria: treatment to face with any energy device within 6 months tanning within 7 days dermabrasion or chemical peel within 3 months current use of systemic retinoids keloidal scaring in the treatment area use of systemic steroids within 6 months use of topical products with retinoid, alpha-hydroxyacid, salicylic acid, vitamin C or E within 14 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Device: Hybrid fractional laser<br>* two treatments given one month apart<br>Other: Alastin Regenerating Skin Nectar with TriHex Technology<br>* applied twice daily<br>|
| Placebo Comparator: Control<br> | Device: Hybrid fractional laser<br>* two treatments given one month apart<br>Other: Cetaphil face cream<br>* applied twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Erythema | A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit. | baseline to day 34 | 
| Mean Change From Baseline in Erythema | A colorimeter will be used to measure the erythema index. The range of the index is 0-99 with 0 indicating better outcome. Erythema will be measured at baseline and at follow-up visits. The mean change from baseline will be averaged to get the overall mean for each arm at each follow up visit. | baseline to day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Skin Barrier Function | Barrier function will be measured by transepidermal water loss in grams/m2(hour). The lower the water loss the better the barrier function of the skin. Barrier function will be measured at baseline, days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change from baseline, at each follow-up visit, will be averaged to get the overall mean for each arm. | baseline to day 34 | 
| Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale | The Global Aesthetic Improvement Scale measures the appearance of the skin as reported by the participant. 1=worse; appearance has worsened compared with the original condition, 2=no change; appearance remains the same as the original condition, 3=improved; better than the initial condition, 4=much improved; marked improvement but not completely optimal, 5=very much improved; excellent or exceptional improvement. The number of participants within each grade will be reported. | baseline to day 90 |