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Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

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ClinicalTrials.gov Identifier: NCT04606134
Recruitment Status : Completed
First Posted : October 28, 2020
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Mara Weinstein Velez, MD, 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.

Condition or disease Intervention/treatment Phase
Acne Scars - Mixed Atrophic and Hypertrophic Device: Hybrid fractional laser Other: Alastin Regenerating Skin Nectar with TriHex Technology Other: Cetaphil face cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : February 13, 2020
Actual Primary Completion Date : June 18, 2021
Actual Study Completion Date : June 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

Arm Intervention/treatment
Experimental: Experimental Device: Hybrid fractional laser
two treatments given one month apart

Other: Alastin Regenerating Skin Nectar with TriHex Technology
applied twice daily

Placebo Comparator: Control Device: Hybrid fractional laser
two treatments given one month apart

Other: Cetaphil face cream
applied twice daily




Primary Outcome Measures :
  1. Mean change 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 to X with 0 indicating better outcome. Erythema will be measured at days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change for each laser treatment will be averaged to get the overall mean for each arm.


Secondary Outcome Measures :
  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 days of laser treatment and 4 days after treatment. Laser treatment will occur at baseline and day 30. The mean change for each laser treatment will be averaged to get the overall mean for each arm.

  2. Mean change in Global Aesthetic Improvement Scale [ Time Frame: baseline to day 90 ]
    The Global Aesthetic Improvement Scale ranges from 1 to 5 with lower numbers indicating better outcomes. (1 = very much improved,2 = marked improvement, 3 = improved, 4 = no change, 5 = worse)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606134


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Responsible Party: Mara Weinstein Velez, MD, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04606134    
Other Study ID Numbers: STUDY00003126
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertrophy
Pathological Conditions, Anatomical