Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

Not Applicable

Completed

• Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
• Interventions: Device: Hybrid fractional laser; Other: Alastin Regenerating Skin Nectar with TriHex Technology; Other: Cetaphil face cream

• Registration Number: NCT04606134
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-13
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-28
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Results First Submitted: 2022-07-19
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Results First Posted: 2023-04-13
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Alastin Regenerating Skin Nectar with TriHex Technology	-
Control	Hybrid fractional laser	-
Control	Cetaphil face cream	-
Experimental	Hybrid fractional laser	-

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Erythema	baseline to day 4	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale	baseline to day 90	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.
Mean Change in Skin Barrier Function	baseline to day 34	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States