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Comparison of 1,550 and 755 Laser in a Split-face Trial

Not Applicable
Completed
Conditions
Acne Scars - Mixed Atrophic and Hypertrophic
Registration Number
NCT03988049
Lead Sponsor
David Smart
Brief Summary

Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Patients will receive laser treatments at week 0, week 4, and week 8. Photographs will be taken prior to laser treatment at each visit, and at the week 24 follow-up visit. Photographs will be reviewed by blinded assessors to rate each side of the face and change from baseline photos.

Detailed Description

This is a Clinical Trial comparing the 1,550-nanometer fractionated photothermolysis system laser to the 755 nanometer picosecond laser using a split-face (Right-Left) comparison. Both of these lasers are currently FDA approved for acne scarring.

Approximately 18 subjects, men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.

Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.

Patients will have photographs taken at every visit prior to the laser treatments at week 0, week 4, and week 8. Photographs will also be taken at the week 24 follow-up visit. Photos will then be assessed by qualified blinded reviewers for comparison.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
Inclusion Criteria
  • Men and women with Fitzpatrick skin types I through V and facial acne scarring of grades III-IV (moderate to severe) will be enrolled. Both sides of the participants' face should have similar amount and severity of acne scarring. Participants will be over 18 years old. Patients have to be otherwise healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity.
Exclusion Criteria
  • Patients have to be overall healthy without a history of skin cancer, keloidal scarring, localized or active infection, immunodeficiency disorders, and light sensitivity. Per PI discretion, any serious medical condition that may interfere with the study. In addition, patients who have been taking isotretinoin for a period of 6 months before treatment will be excluded.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo ReviewerPhotos will be taken at week 0, week 4, week 8, and week 24.

Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Utah MidValley Dermatology

🇺🇸

Murray, Utah, United States

University of Utah MidValley Dermatology
🇺🇸Murray, Utah, United States

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