Clinical trial NCT00585286: Fractional Resurfacing Device for Treatment of Acne Scarring
Official title: Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne
Scar
Keywords: acne vulgaris
scarring
laser
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Reliant Technologies, Inc. Mountain View, CA
name: University of Minnesota
First posted: 2008-01-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Overall Improvement of Acne Scarring
timeFrame: Baseline, 1 month and 3 months post-treatment
measure: Average Improvement in Surface Texture
timeFrame: Baseline, 1 month and 3 months post-treatment
measure: Degree of Atrophy
timeFrame: Baseline, 1 month and 3 months post-treatment
Secondary outcomes:
measure: Pain Tolerance
timeFrame: At treatment visit (up to 3 visits)
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine Dermatology Clinical Research Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Christopher B Zachary, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
name: Brian D Zelickson, MD
role: PRINCIPAL_INVESTIGATOR
References: