NCT01773343

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

January 2, 2013

Last Update Submit

January 18, 2013

Conditions

Atrophic Acne Scars

Keywords

skin texture, efficacy, adverse effects

Outcome Measures

Primary Outcomes (1)

  • Change in scar texture

    24 weeks

Secondary Outcomes (1)

  • Appearance of erythema, oedema, pigmentation, infection

    24 weeks

Study Arms (2)

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

LaserPROCEDURE

Fractionel CO2 laser: 1 versus 3 months intervals

Also known as: Fractionel CO2 laser
CO2 laser at 1 month intervalCO2 laser at 3 monrths interval

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Lene Hedelund, MD, PhD

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 23, 2013

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

DK(1)