Treatment of Atrophic Acne Scars With a Fractional CO2 La... | NCT01773343

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

NCT01773343

Sponsor

Aarhus University Hospital

Status

Unknown status

Last Update Posted

Jan 23, 2013Estimated

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Atrophic Acne Scars

Interventions

Laser

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
20110102	Registry Identifier	20110102

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jan 2013Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Jan 2, 2013

First Submission Date that Met QC Criteria

Jan 18, 2013

First Posted Date

Jan 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2013

Last Update Posted Date

Jan 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CO2 laser at 1 month interval	Active Comparator	CO2 laser treatment of mild to severe acne scars at 1 month interval	Procedure: Laser
CO2 laser at 3 monrths interval	Active Comparator	CO2 laser treatment of mild to severe acne scars at 3 month intervals	Procedure: Laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser	Procedure	Fractionel CO2 laser: 1 versus 3 months intervals	CO2 laser at 1 month interval CO2 laser at 3 monrths interval

Measure	Description	Time Frame
Change in scar texture		24 weeks

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene Hedelund, MD, PhD	Aarhus University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus	Aarhus C	8000	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D007834	Lasers

Ancestor Terms

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided