Back to resultsTreatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals
Primary Purpose
Atrophic Acne Scars
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Laser
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Acne Scars focused on measuring skin texture, efficacy, adverse effects
Eligibility Criteria
Inclusion Criteria:
- Have Fitzpatrick skin type I-III. (•Are male or female.
- Are between 18 and 60 years of age.
- Mild to severe acne scarring.
- Are able to read, understand, and sign the Informed Consent.
- Are willing and able to comply with all follow-up requirements -
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 been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Pregnancy
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CO2 laser at 1 month interval
CO2 laser at 3 monrths interval
Arm Description
CO2 laser treatment of mild to severe acne scars at 1 month interval
CO2 laser treatment of mild to severe acne scars at 3 month intervals
Outcomes
Primary Outcome Measures
Change in scar texture
Secondary Outcome Measures
Appearance of erythema, oedema, pigmentation, infection
Full Information
NCT ID
NCT01773343
First Posted
January 2, 2013
Last Updated
January 18, 2013
Sponsor
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01773343
Brief Title
Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals
Official Title
Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals. A Randomized Controlled Trial With Blinded Response Evaluations
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with 1 versus 3 months intervals
Detailed Description
Change in scar texture evaluated by blinded evalutaions. Appearance of erythema, oedema, pigmentation, infection after treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Acne Scars
Keywords
skin texture, efficacy, adverse effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CO2 laser at 1 month interval
Arm Type
Active Comparator
Arm Description
CO2 laser treatment of mild to severe acne scars at 1 month interval
Arm Title
CO2 laser at 3 monrths interval
Arm Type
Active Comparator
Arm Description
CO2 laser treatment of mild to severe acne scars at 3 month intervals
Intervention Type
Procedure
Intervention Name(s)
Laser
Other Intervention Name(s)
Fractionel CO2 laser
Intervention Description
Fractionel CO2 laser: 1 versus 3 months intervals
Primary Outcome Measure Information:
Title
Change in scar texture
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Appearance of erythema, oedema, pigmentation, infection
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have Fitzpatrick skin type I-III. (•Are male or female.
Are between 18 and 60 years of age.
Mild to severe acne scarring.
Are able to read, understand, and sign the Informed Consent.
Are willing and able to comply with all follow-up requirements -
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 been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene Hedelund, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals
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