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

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 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.

Study Overview

• Status: Completed
• Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
• Intervention / Treatment: Device: 1,550 fracionated photothermolysis laser; Device: 755 picosecond laser

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah MidValley Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1,550 laser; This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser.	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.
Active Comparator: 755 laser; This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser.	Device: 755 picosecond laser; All subjects will have one side of their face treated with one laser, and the other side with the other laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: David Smart
• Investigators: Principal Investigator: David R Smart, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: IRB_00095294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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