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

Tracking Information

• First Submitted Date: December 6, 2017
• First Posted Date: June 17, 2019
• Last Update Posted Date: January 27, 2020
• Actual Study Start Date: March 8, 2017
• Actual Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2019)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Acne Scars - Mixed Atrophic and Hypertrophic

Intervention

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.

Study Arms

• 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.
  Intervention: Device: 1,550 fracionated photothermolysis laser vs. 755 picosecond 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.
  Intervention: Device: 1,550 fracionated photothermolysis laser vs. 755 picosecond laser

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 14, 2019): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 30, 2019
• Actual Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03988049
• Other Study ID Numbers: IRB_00095294
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: David Smart, University of Utah
• Study Sponsor: David Smart
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Utah
• Verification Date: January 2020