Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

Acne Scars - Mixed Atrophic and Hypertrophic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606134
• Other study ID #: STUDY00003126
• Status: Completed
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: June 18, 2021

Study information

• Verified date: April 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 18, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acne Scars - Mixed Atrophic and Hypertrophic
• Hypertrophy

Intervention

Device:
• Hybrid fractional laser
two treatments given one month apart

Other:
• Alastin Regenerating Skin Nectar with TriHex Technology
applied twice daily
• Cetaphil face cream
applied twice daily

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	baseline to day 34
Secondary	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.	baseline to day 90