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Completed

NCT Number: NCT00585286

Fractional Resurfacing Device for Treatment of Acne Scarring

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).

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UC Irvine Dermatology Clinical Research Center

Irvine, California, 92697, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Fraxel Re:pair laser

Primary outcomes

  1. Overall Improvement of Acne Scarring

    Time frame: Baseline, 1 month and 3 months post-treatment

    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).

  2. Average Improvement in Surface Texture

    Time frame: Baseline, 1 month and 3 months post-treatment

    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).

  3. Degree of Atrophy

    Time frame: Baseline, 1 month and 3 months post-treatment

    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 outcomes

  1. Pain Tolerance

    Time frame: At treatment visit (up to 3 visits)

    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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Reliant Technologies, Inc. Mountain View, CA
  • University of Minnesota

Registry information

Official study title

Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 3, 2008
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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