Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

University of Rochester10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Interventions

Hybrid fractional laserDEVICE

two treatments given one month apart

Alastin Regenerating Skin Nectar with TriHex TechnologyOTHER

applied twice daily

Cetaphil face creamOTHER

applied twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline to day 34

Mean Change From Baseline in Erythema

Time frame: baseline to day 4

Secondary Outcomes

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.

Time frame: 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.

Time frame: baseline to day 90

Data from ClinicalTrials.gov

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