NCT04606134

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

Completed NA Results posted Last updated 13 April 2023

What this trial tests

NA trial testing Hybrid fractional laser in Acne Scars - Mixed Atrophic and Hypertrophic in 10 participants. Completed in 18 June 2021.

Timeline

13 February 2020

Primary endpoint
18 June 2021

18 June 2021

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	10
Start date	13 February 2020
Primary completion	18 June 2021
Estimated completion	18 June 2021
Sites	1 location across United States

Drugs / interventions tested

• Hybrid fractional laser
• Alastin Regenerating Skin Nectar with TriHex Technology
• Cetaphil face cream

Conditions studied

• Acne Scars - Mixed Atrophic and Hypertrophic — all drugs for Acne Scars - Mixed Atrophic and Hypertrophic →

Sponsor

University of Rochester

Who can join

18 and older, any sex, with Acne Scars - Mixed Atrophic and Hypertrophic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline in Erythema Primary · baseline to day 34

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.

Group	Value	95% CI
Experimental	-1.687	± 4.461
Control	5.730	± 4.461

Mean Change in Skin Barrier Function Secondary · 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.

Day 4

Group	Value	95% CI
Experimental	6.502	± 6.650
Control	21.59	± 6.650

Day 34

Group	Value	95% CI
Experimental	2.858	± 7.233
Control	39.07	± 7.233

Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale Secondary · 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.

Improved

Group	Value	95% CI
Experimental	4
Control	1

No Change

Group	Value	95% CI
Experimental	2
Control	1

Much Improved

Group	Value	95% CI
Experimental	0
Control	1

Mean Change From Baseline in Erythema Primary · 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.

Group	Value	95% CI
Experimental	1.768	± 4.218
Control	5.596	± 4.218

Adverse events — posted to ClinicalTrials.gov

Time frame: through study completion, approximately 90 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental

Serious: 0/6 (0%)

Deaths: 0/6

Control

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (1 terms — click to expand)

Reaction	System	Experimental	Control
Melasma	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04606134 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148