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

NCT ID: NCT01773343

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Atrophic Acne Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CO2 laser at 1 month interval

CO2 laser treatment of mild to severe acne scars at 1 month interval

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type PROCEDURE

Fractionel CO2 laser: 1 versus 3 months intervals

CO2 laser at 3 monrths interval

CO2 laser treatment of mild to severe acne scars at 3 month intervals

Group Type ACTIVE_COMPARATOR

Laser

Intervention Type PROCEDURE

Fractionel CO2 laser: 1 versus 3 months intervals

Interventions

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Laser

Fractionel CO2 laser: 1 versus 3 months intervals

Intervention Type PROCEDURE

Other Intervention Names

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Fractionel CO2 laser

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lene Hedelund, MD, PhD

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, Aarhus C, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20110102

Identifier Type: REGISTRY

Identifier Source: secondary_id

100169

Identifier Type: -

Identifier Source: org_study_id

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