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Fractional Resurfacing Device for Treatment of Acne Scarring

Primary Purpose

Acne, Scar

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
10,600 nm fractional carbon dioxide laser system
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring acne vulgaris, scarring, laser

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UC Irvine Dermatology Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fractional carbon dioxide laser system

Arm Description

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
December 26, 2007
Last Updated
December 13, 2013
Sponsor
University of California, Irvine
Collaborators
Reliant Technologies, Inc. Mountain View, CA, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00585286
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Reliant Technologies, Inc. Mountain View, CA, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Scar
Keywords
acne vulgaris, scarring, laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional carbon dioxide laser system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
10,600 nm fractional carbon dioxide laser system
Other Intervention Name(s)
Fraxel Re:pair laser
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Improvement of Acne Scarring
Description
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).
Time Frame
Baseline, 1 month and 3 months post-treatment
Title
Average Improvement in Surface Texture
Description
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).
Time Frame
Baseline, 1 month and 3 months post-treatment
Title
Degree of Atrophy
Description
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).
Time Frame
Baseline, 1 month and 3 months post-treatment
Secondary Outcome Measure Information:
Title
Pain Tolerance
Description
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.
Time Frame
At treatment visit (up to 3 visits)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher B Zachary, MBBS, FRCP
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian D Zelickson, MD
Organizational Affiliation
Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Irvine Dermatology Clinical Research Center
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States

12. IPD Sharing Statement

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Fractional Resurfacing Device for Treatment of Acne Scarring

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