Fractional Resurfacing Device for Treatment of Acne Scarring

NCT ID: NCT00585286

Last Updated: 2014-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2008-07-31

Brief Summary

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).

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

Conditions

Acne; Scar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

10,600 nm fractional carbon dioxide laser system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Fraxel Re:pair laser

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reliant Technologies, Inc. Mountain View, CA

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Christopher Zachary

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher B Zachary, MBBS, FRCP

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Brian D Zelickson, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University of Minnesota, Minneapolis, Minnesota

Locations

UC Irvine Dermatology Clinical Research Center

Irvine, California, United States

Countries

United States

Related Links

http://www.dermatology.uci.edu/clinical_trials.html

University of California, Irvine Department of Dermatology Clinical Research

Other Identifiers

2006-5328

Identifier Type: -

Identifier Source: org_study_id