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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier:
NCT01773343
First received: January 2, 2013
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Atrophic Acne Scars
Procedure: Laser

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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change in scar texture [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Appearance of erythema, oedema, pigmentation, infection [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: November 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Fractionel CO2 laser

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773343

Locations
Denmark
Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Investigators
Study Director: Lene Hedelund, MD, PhD Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus ( Aarhus University Hospital )
ClinicalTrials.gov Identifier: NCT01773343     History of Changes
Other Study ID Numbers: 100169, 20110102
Study First Received: January 2, 2013
Last Updated: January 18, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
skin texture, efficacy, adverse effects

Additional relevant MeSH terms:
Acne Vulgaris
Cicatrix
Atrophy
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014