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

Acne Scars - Mixed Atrophic and Hypertrophic Clinical Trial

Official title:

Comparison of a 1,550 Nanometer Erbium: Glass Fractional Laser and 755-nanometer Alexandrite Picosecond Pulse Duration Laser With Diffractive Lens Array in the Treatment of Acne Scars: a Randomized, Split-face Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988049
• Other study ID #: IRB_00095294
• Status: Completed
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: June 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 30, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Scars - Mixed Atrophic and Hypertrophic
• Hypertrophy

Intervention

Device:
• 1,550 fracionated photothermolysis laser
All subjects will have one side of their face treated with one laser, and the other side with the other laser.
• 755 picosecond laser
All subjects will have one side of their face treated with one laser, and the other side with the other laser.

Locations

Country	Name	City	State
United States	University of Utah MidValley Dermatology	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
David Smart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer	Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs.	Photos will be taken at week 0, week 4, week 8, and week 24.