Fractional Resurfacing Device for Treatment of Acne Scarring - Full Text View

Sponsor:	University of California, Irvine
Collaborator:	Reliant Technologies, Inc. Mountain View, CA
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00585286

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 Scarring	Device: 10,600 nm fractional CO2 laser system	Phase I Phase II

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:

MedlinePlus related topics: Acne Scars

Drug Information available for: Carbon dioxide

U.S. FDA Resources

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

Primary Outcome Measures:

Overall improvement of acne scarring [ Time Frame: 72 hours, 1 week, 1 month and 3 months post-treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

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: A Fractional CO2 laser treatment	Device: 10,600 nm fractional CO2 laser system 1-3 laser treatments using 20-70 mJ with 600-1200 MTZ/cm2

Detailed Description:

Fifteen subjects with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and IRB approved 10,600nm fractional CO2 laser system. Improvement of acne scarring is evaluated at 72 hours, 1 week, 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 evaluted 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:	30 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

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

Investigators

Principal Investigator:

Christopher B Zachary, MBBS, FRCP

University of California, Irvine

More Information

Additional Information:

UC Irvine Department of Dermatology Clinical Research This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Christopher B. Zachary, MBBS, FRCP, University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00585286 History of Changes
Other Study ID Numbers:	2006-5328
Study First Received:	December 26, 2007
Last Updated:	April 29, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Irvine:

acne vulgaris
scarring
laser

Additional relevant MeSH terms:

Acne Vulgaris
Cicatrix
Acneiform Eruptions
Skin Diseases

Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012