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
  Purpose

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).


Condition Intervention Phase
Acne
Scar
Device: 10,600 nm fractional carbon dioxide laser system
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585286

Locations
United States, California
UC Irvine Dermatology Clinical Research Center
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Reliant Technologies, Inc. Mountain View, CA
University of Minnesota - Clinical and Translational Science Institute
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher Zachary, Clinical Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00585286     History of Changes
Other Study ID Numbers: 2006-5328
Study First Received: December 26, 2007
Results First Received: June 17, 2011
Last Updated: December 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Irvine:
acne vulgaris
scarring
laser

ClinicalTrials.gov processed this record on September 18, 2014