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Completed

NCT Number: NCT04606134

Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

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.

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Key information

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid fractional laser

Device

two treatments given one month apart

Alastin Regenerating Skin Nectar with TriHex Technology

Other

applied twice daily

Cetaphil face cream

Other

applied twice daily

Primary outcomes

  1. Mean Change From Baseline in Erythema

    Time frame: 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.

  2. Mean Change From Baseline in Erythema

    Time frame: 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 outcomes

  1. Mean Change in Skin Barrier Function

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Single Center, Prospective, Blinded Study to Evaluate the Efficacy and Safety of a Tripeptide/Hexapeptide Topical When Used With Er:YAG Hybrid Laser for the Treatment of Acne Scars

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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