Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals

Treatment of Atrophic Acne Scars With a Fractional CO2 Laser at 1 Versus 3 Months Intervals. A Randomized Controlled Trial With Blinded Response Evaluations

To compare efficacy and adverse effects of fractional CO2 laser of acne scars treatment with 1 versus 3 months intervals

Study Overview

• Status: Unknown
• Conditions: Atrophic Acne Scars
• Intervention / Treatment: Procedure: Laser

Detailed Description

Change in scar texture evaluated by blinded evalutaions. Appearance of erythema, oedema, pigmentation, infection after treatment

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C
    • Aarhus, Aarhus C, Denmark, 8000
      • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CO2 laser at 1 month interval; CO2 laser treatment of mild to severe acne scars at 1 month interval	Procedure: Laser; Fractionel CO2 laser: 1 versus 3 months intervals; Other Names: Fractionel CO2 laser
ACTIVE_COMPARATOR: CO2 laser at 3 monrths interval; CO2 laser treatment of mild to severe acne scars at 3 month intervals	Procedure: Laser; Fractionel CO2 laser: 1 versus 3 months intervals; Other Names: Fractionel CO2 laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in scar texture	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Appearance of erythema, oedema, pigmentation, infection	24 weeks

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Study Director: Lene Hedelund, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ANTICIPATED): January 1, 2013
• Study Completion (ANTICIPATED): January 1, 2013

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (ESTIMATE): January 23, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: skin texture, efficacy, adverse effects
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 100169; 20110102 (20110102)