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

NCT03988049 | Completed Results FDA Device

• 1 other identifier: IRB_00095294
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

1,550 laser

ACTIVE COMPARATOR

This arm is the side of the face treated with the 1550-nanometer Fracionated Photothermolysis laser.

Device: 1,550 fracionated photothermolysis laser

755 laser

ACTIVE COMPARATOR

This arm is the side of the face treated with the 755-nanometer alexandrite picosecond laser.

Device: 755 picosecond laser

Interventions

1,550 fracionated photothermolysis laser DEVICE

All subjects will have one side of their face treated with one laser, and the other side with the other laser.

1,550 laser

755 picosecond laser DEVICE

All subjects will have one side of their face treated with one laser, and the other side with the other laser.

755 laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Smart: lead

Study Sites (1)

University of Utah MidValley Dermatology

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Smart, Assistant Professor, Dermatology
• Organization: University of Utah Dermatology

david.smart@hsc.utah.edu

8015816465

Study Officials

• David R Smart, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded Assessors will be reviewing and scoring the photos after the study is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: June 17, 2019
• Study Start: March 8, 2017
• Primary Completion: August 1, 2019
• Study Completion: October 30, 2019
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)