Back to resultsTripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hybrid fractional laser
Alastin Regenerating Skin Nectar with TriHex Technology
Cetaphil face cream
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic
Eligibility 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
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Mean Change in Skin Barrier Function
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.
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale
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.
Full Information
NCT ID
NCT04606134
First Posted
October 21, 2020
Last Updated
April 11, 2023
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT04606134
Brief Title
Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Hybrid fractional laser
Intervention Description
two treatments given one month apart
Intervention Type
Other
Intervention Name(s)
Alastin Regenerating Skin Nectar with TriHex Technology
Intervention Description
applied twice daily
Intervention Type
Other
Intervention Name(s)
Cetaphil face cream
Intervention Description
applied twice daily
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Erythema
Description
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.
Time Frame
baseline to day 34
Title
Mean Change From Baseline in Erythema
Description
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.
Time Frame
baseline to day 4
Secondary Outcome Measure Information:
Title
Mean Change in Skin Barrier Function
Description
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.
Time Frame
baseline to day 34
Title
Number of Participants Who Scored Skin Appearance as no Change, Improved or Much Improved Using the Global Aesthetic Improvement Scale
Description
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.
Time Frame
baseline to day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring
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