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

Atrophic Acne Scars Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01773343
• Other study ID #: 100169
• Secondary ID: 20110102
• Status: Active, not recruiting
• Phase: N/A
• First received: January 2, 2013
• Last updated: January 18, 2013
• Start date: November 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophic Acne Scars
• Atrophy

Intervention

Procedure:
• Laser
Fractionel CO2 laser: 1 versus 3 months intervals

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in scar texture		24 weeks	No
Secondary	Appearance of erythema, oedema, pigmentation, infection		24 weeks	Yes