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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 : Unknown
Verified March 2008 by Henry Ford Health System.
Recruitment status was:  Active, not recruiting
First Posted : March 24, 2008
Last Update Posted : March 24, 2008
Sponsor:
Information provided by:
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 24, 2008
Study Start Date  ICMJE September 2007
Estimated Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
Improvement in acne scarring. [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
  • Dyspigmentation [ Time Frame: 6 months ]
  • Pain with treatment [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group 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: 1
    Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.
    Intervention: Procedure: Fractionated Laser Resurfacing
  • Experimental: 2
    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 Unknown status
Actual Enrollment  ICMJE
 (submitted: March 21, 2008)
15
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2008
Estimated 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
Responsible Party David Ozog, MD/ Director Cosmetic Dermatology, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
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 2008

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