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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04606134
Other study ID # STUDY00003126
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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