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Fractional Resurfacing Device for Treatment of Acne Scarring

This study has been completed.
Sponsor:
Collaborators:
Reliant Technologies, Inc. Mountain View, CA
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Christopher Zachary, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585286
First received: December 26, 2007
Last updated: December 13, 2013
Last verified: December 2013

December 26, 2007
December 13, 2013
March 2007
July 2008   (final data collection date for primary outcome measure)
  • Overall Improvement of Acne Scarring [ Time Frame: Baseline, 1 month and 3 months post-treatment ] [ Designated as safety issue: Yes ]
    Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
  • Average Improvement in Surface Texture [ Time Frame: Baseline, 1 month and 3 months post-treatment ] [ Designated as safety issue: No ]
    Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
  • Degree of Atrophy [ Time Frame: Baseline, 1 month and 3 months post-treatment ] [ Designated as safety issue: No ]
    Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
Overall improvement of acne scarring [ Time Frame: 72 hours, 1 week, 1 month and 3 months post-treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00585286 on ClinicalTrials.gov Archive Site
Pain Tolerance [ Time Frame: At treatment visit (up to 3 visits) ] [ Designated as safety issue: Yes ]
The average pain score reported over all three treatments was 5.67, corresponding to "moderate" pain based on a 10-point scale. The pain score is recorded on a 10-point scale, with 0 being "no pain" and 10 being "worst pain imaginable." All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure. Increased pain scores correlated with increased density, but not increased energy.
  • Safety [ Time Frame: During each treatment and 3 days - 3 months after each treatment ] [ Designated as safety issue: Yes ]
  • Pain assessment [ Time Frame: At each laser treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Fractional Resurfacing Device for Treatment of Acne Scarring
Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring

The purpose of this research study is to evaluate the safety and effectiveness of a new investigational laser device for treatment of acne scarring, for improvement in the appearance of surface texture and topography (recessed or uneven surfaces).

Thirty subjects between two research locations with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved 10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at 1 month and 3 months post-treatment.

Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation.

The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acne
  • Scar
Device: 10,600 nm fractional carbon dioxide laser system
1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
Other Name: Fraxel Re:pair laser
Experimental: Fractional carbon dioxide laser system
Thirty total healthy subjects from two research centers with skin type I-IV of moderate to severe acne scarring received treatment with the 10,600 nm fractional carbon dioxide laser system.
Intervention: Device: 10,600 nm fractional carbon dioxide laser system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have Fitzpatrick skin type I-V. (Type I is blonde/red hair with freckles and Type V are Hispanics and lighter African Americans.)
  • Are male or female.
  • Are between 18 and 75 years of age.
  • Have moderate to severe acne scarring. Acne scarring will be assessed with the Acne Scar Severity Scale. Subjects will be eligible for treatment if the area to be treated is scored as having an Acne Scar Severity Score > 4 according to the Acne Scar Severity Scale (0-9).
  • Are able to read, understand, and sign the Informed Consent.
  • Are willing and able to comply with all follow-up requirements for a minimum of 8 months.

Exclusion Criteria:

  • Have had active localized or systemic infections within 6 months of enrollment
  • Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
  • Have immunocompromised status (inability to resist infection, etc.)
  • Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
  • Have taken Accutane within 12 months of enrollment
  • Are allergic to lidocaine (skin numbing agent)
  • Are allergic to Valtrex (an anti-viral medication)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00585286
2006-5328
Yes
Christopher Zachary, University of California, Irvine
University of California, Irvine
  • Reliant Technologies, Inc. Mountain View, CA
  • University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Christopher B Zachary, MBBS, FRCP University of California, Irvine
Principal Investigator: Brian D Zelickson, MD Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
University of California, Irvine
December 2013

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