Comparison of 1,550 and 755 Laser in a Split-face Trial
Primary Purpose
Acne Scars - Mixed Atrophic and Hypertrophic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
1,550 fracionated photothermolysis laser
755 picosecond laser
Sponsored by
About this trial
This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic
Eligibility Criteria
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.
Sites / Locations
- University of Utah MidValley Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1,550 laser
755 laser
Arm Description
This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser.
This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03988049
Brief Title
Comparison of 1,550 and 755 Laser in a Split-face 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Smart
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All subjects will receive half of their faces treated with each laser. Subjects will be randomized to determine which side of the face is treated with each laser.
Masking
Outcomes Assessor
Masking Description
Blinded Assessors will be reviewing and scoring the photos after the study is completed.
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1,550 laser
Arm Type
Active Comparator
Arm Description
This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser.
Arm Title
755 laser
Arm Type
Active Comparator
Arm Description
This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser.
Intervention Type
Device
Intervention Name(s)
1,550 fracionated photothermolysis laser
Intervention Description
All subjects will have one side of their face treated with one laser, and the other side with the other laser.
Intervention Type
Device
Intervention Name(s)
755 picosecond laser
Intervention Description
All subjects will have one side of their face treated with one laser, and the other side with the other laser.
Primary Outcome Measure Information:
Title
Number of Half Faces to Achieve at Least 25% Improvement in Acne Scarring at Week 24 by Blinded Photo Reviewer
Description
Change in Baseline acne scarring compared to week 24 measured by photographic review. Measured by blinded reviewer assessments of photographs.
Time Frame
Photos will be taken at week 0, week 4, week 8, and week 24.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Smart, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah MidValley Dermatology
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of 1,550 and 755 Laser in a Split-face Trial
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