Overview

This trial is active, not recruiting.

Condition atrophic acne scars
Treatment laser
Sponsor Aarhus University Hospital
Start date November 2011
End date January 2013
Trial size 12 participants
Trial identifier NCT01773343, 100169, 20110102

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
CO2 laser treatment of mild to severe acne scars at 1 month interval
laser Fractionel CO2 laser
Fractionel CO2 laser: 1 versus 3 months intervals
(Active Comparator)
CO2 laser treatment of mild to severe acne scars at 3 month intervals
laser Fractionel CO2 laser
Fractionel CO2 laser: 1 versus 3 months intervals

Primary Outcomes

Measure
Change in scar texture
time frame: 24 weeks

Secondary Outcomes

Measure
Appearance of erythema, oedema, pigmentation, infection
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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
Description Change in scar texture evaluated by blinded evalutaions. Appearance of erythema, oedema, pigmentation, infection after treatment
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by University of Aarhus.