Fractional Resurfacing Device for Treatment of Acne Scarring

NCT00585286 | Completed Phase 1 Results DMC

• 1 other identifier: 2006-5328
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Acne; Scar

Keywords

acne vulgaris; scarring; laser

Outcome Measures

Primary Outcomes (3)

• Overall Improvement of Acne Scarring

  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).

  Baseline, 1 month and 3 months post-treatment

• Average Improvement in Surface Texture

  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).

  Baseline, 1 month and 3 months post-treatment

• Degree of Atrophy

  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).

  Baseline, 1 month and 3 months post-treatment

Secondary Outcomes (1)

• Pain Tolerance

  At treatment visit (up to 3 visits)

Study Arms (1)

Fractional carbon dioxide laser system

EXPERIMENTAL

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

Interventions

10,600 nm fractional carbon dioxide laser system 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

Also known as: Fraxel Re:pair laser

Fractional carbon dioxide laser system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Irvine: lead
• Reliant Technologies, Inc. Mountain View, CA: collaborator
• University of Minnesota: collaborator

Study Sites (1)

UC Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

Location

Related Links

• University of California, Irvine Department of Dermatology Clinical Research

MeSH Terms

Conditions

Acne Vulgaris; Cicatrix

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

There were no major limitations to this trial. The trial was completed without any technical problems or major complications.

Results Point of Contact

• Title: Christopher Zachary, FRCP, MBBS/Prinicipal Investigator
• Organization: University of California, Irvine

czachary@uci.edu

(949) 824-7103

Study Officials

• Christopher B Zachary, MBBS, FRCP

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Brian D Zelickson, MD

  Department of Dermatology, University of Minnesota, Minneapolis, Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: March 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 15, 2014
• Results First Posted: December 2, 2013

Record last verified: 2013-12

Locations

US (1)