Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

NCT ID: NCT04606134

Last Updated: 2023-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-13

Study Completion Date

2021-06-18

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.

Detailed Description

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Conditions

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Acne Scars - Mixed Atrophic and Hypertrophic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experimental

Group Type EXPERIMENTAL

Hybrid fractional laser

Intervention Type DEVICE

two treatments given one month apart

Alastin Regenerating Skin Nectar with TriHex Technology

Intervention Type OTHER

applied twice daily

Control

Group Type PLACEBO_COMPARATOR

Hybrid fractional laser

Intervention Type DEVICE

two treatments given one month apart

Cetaphil face cream

Intervention Type OTHER

applied twice daily

Interventions

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Hybrid fractional laser

two treatments given one month apart

Intervention Type DEVICE

Alastin Regenerating Skin Nectar with TriHex Technology

applied twice daily

Intervention Type OTHER

Cetaphil face cream

applied twice daily

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Mara Weinstein Velez, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00003126

Identifier Type: -

Identifier Source: org_study_id

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