Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

NCT04606134 | Completed Results FDA Device

• 1 other identifier: STUDY00003126
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mean Change in Skin Barrier Function

  baseline to day 34

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

  baseline to day 90

Study Arms (2)

Experimental

EXPERIMENTAL

Device: Hybrid fractional laser; Other: Alastin Regenerating Skin Nectar with TriHex Technology

Control

PLACEBO COMPARATOR

Device: Hybrid fractional laser; Other: Cetaphil face cream

Interventions

Hybrid fractional laser DEVICE

two treatments given one month apart

Control; Experimental

Alastin Regenerating Skin Nectar with TriHex Technology OTHER

applied twice daily

Experimental

Cetaphil face cream OTHER

applied twice daily

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mara Weinstein MD
• Organization: University of Rochester Medical Center

Mara_Weinsteinvelez@URMC.Rochester.edu

(585) 275-7546

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: February 13, 2020
• Primary Completion: June 18, 2021
• Study Completion: June 18, 2021
• Last Updated: April 13, 2023
• Results First Posted: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)