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

• ClinicalTrials.gov Identifier: NCT03988049
• Recruitment Status: Completed
• First Posted: June 17, 2019
• Last Update Posted: January 27, 2020
• Sponsor: David Smart
• Information provided by (Responsible Party): David Smart, University of Utah

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.

Condition or disease	Intervention/treatment	Phase
Acne Scars - Mixed Atrophic and Hypertrophic	Device: 1,550 fracionated photothermolysis laser vs. 755 picosecond laser	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Single (Outcomes Assessor)
• Masking Description: Blinded Assessors will be reviewing and scoring the photos after the study is completed.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 8, 2017
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: October 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Right Side 1,550 laser Left Side 755 laser; All subjects on this arm will be treated on this split-faced. The Right side of their face will be treated with the 1,550-nanometer Fracionated Photothermolysis laser, and the left side of their face will be treated with the 755-nanometer alexandrite picosecond laser.	Device: 1,550 fracionated photothermolysis laser vs. 755 picosecond laser; All subjects will have one side of their face treated with one laser, and the other side with the other laser.
Active Comparator: Left Side 1,550 laser Right Side 755 laser; All subjects on this arm will be treated on this split-faced. The left side of their face will be treated with the 1,550-nanometer Fracionated Photothermolysis laser, and the right side of their face will be treated with the 755-nanometer alexandrite picosecond laser.	Device: 1,550 fracionated photothermolysis laser vs. 755 picosecond laser; All subjects will have one side of their face treated with one laser, and the other side with the other laser.

Outcome Measures

Primary Outcome Measures :

1. To measure efficacy and safety of fractionated 1550-nanometer laser and 755-nanometer alexandrite picosecond laser in combination with a diffractive lens array, in treatment of moderate to severe acne scars. [ Time Frame: Photos 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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Utah

University of Utah MidValley Dermatology

Murray, Utah, United States, 84107

Sponsors and Collaborators

David Smart

Investigators

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

More Information

• Responsible Party: David Smart, Principal Investigator, University of Utah
• ClinicalTrials.gov Identifier: NCT03988049
• Other Study ID Numbers: IRB_00095294
• First Posted: June 17, 2019
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Hypertrophy; Pathological Conditions, Anatomical