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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988049
Recruitment Status : Completed
First Posted : June 17, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
David Smart, University of Utah

Tracking Information
First Submitted Date  ICMJE December 6, 2017
First Posted Date  ICMJE June 17, 2019
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE March 8, 2017
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of 1,550 and 755 Laser in a Split-face Trial
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE Acne Scars - Mixed Atrophic and Hypertrophic
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 30, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988049
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party David Smart, University of Utah
Study Sponsor  ICMJE David Smart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David R Smart, MD University of Utah
PRS Account University of Utah
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP