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Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin

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: NCT00641420
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
David M. Ozog, Henry Ford Health System

Tracking Information
First Submitted Date  ICMJE March 17, 2008
First Posted Date  ICMJE March 24, 2008
Last Update Posted Date March 15, 2022
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2022)
Improvement in acne scarring. [ Time Frame: 6 months ]
Blinded evaluators will score improvement of acne via photographs using a quartile grading scale (0 = no improvement, 1 = minor improvement [1-25%], 2 =moderate improvement [26-50%], 3 =marked improvement [51-75%], 4 = very significant improvement [76-100%]).
Original Primary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
Improvement in acne scarring. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2022)
  • Dyspigmentation [ Time Frame: 6 months ]
    dyspigmentation will be assessed separately from acne scarring via photographs with blinded evaluators on a scale of 1- 3. 1 (minimal amount of hyperpigmentation), 2 (moderate hyperpigmentation) and 3 (severe amount of hyperpigmentation) depending on the degree of hyperpigmentation compared with their baseline photo.
  • Pain with treatment [ Time Frame: 5 months ]
    subjects will report any pain with treatment on a 0-10 scale, with zero indicating no pain and 10 indicating the worst pain
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
  • Dyspigmentation [ Time Frame: 6 months ]
  • Pain with treatment [ Time Frame: 5 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Official Title  ICMJE Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Brief Summary Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
Detailed Description

Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they have a high risk of complications. Fractional lasers have less severe side effects but more moderate efficacy than ablative devices. Studies were performed in individuals with Fitzpatrick skin type I to VI.

Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI.

Methods: We conducted a prospective, single-blind, randomized trial in patients with acne scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed. A patient questionnaire was distributed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Scarring
Intervention  ICMJE Procedure: Fractionated Laser Resurfacing
Other Name: Fractionated Laser: FRAXEL
Study Arms  ICMJE
  • Experimental: Fractional Laser 10mJ
    Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.
    Intervention: Procedure: Fractionated Laser Resurfacing
  • Experimental: Fractional Laser 40mJ
    Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.
    Intervention: Procedure: Fractionated Laser Resurfacing
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: March 21, 2008)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators
  • Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring
  • Patients able to follow instructions
  • If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex
  • Written informed consent from the patients (Appendix II)

Exclusion Criteria:

  • Children (less than 18 years old)
  • Pregnant or lactating women
  • Personal history of keloids or hypertrophic scarring
  • Active acne requiring topical or oral therapy
  • Accutane or other oral retinoid in past year
  • Patients with a known allergy to lidocaine
  • Allergy to valacyclovir in a patient that needs prophylaxis
  • Patients with an unstable or non controlled underlying medical problem
  • Patients who are not able to follow instructions
  • Patients who have participated in a study within the 3 months prior to study entry
  • Patients who refuse to give written informed consent
  • Patients with a history of a pigmentary abnormality
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00641420
Other Study ID Numbers  ICMJE HenryFord4447
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party David M. Ozog, Henry Ford Health System
Original Responsible Party David Ozog, MD/ Director Cosmetic Dermatology, Henry Ford Health System
Current Study Sponsor  ICMJE Henry Ford Health System
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M Ozog, MD Henry Ford Health System
PRS Account Henry Ford Health System
Verification Date March 2022

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