Fractional Resurfacing Device for Treatment of Acne Scarring

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acne, Scar

Intervention / Treatment
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* Device: 10,600 nm fractional carbon dioxide laser system


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional carbon dioxide laser system<br>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<br>* 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<br>* Other names: Fraxel Re:pair laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Tolerance | 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. | At treatment visit (up to 3 visits) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne vulgaris, scarring, laser