NCT00969215

Brief Summary

The purpose of this study is to determine if fractional carbon dioxide laser treatment of a burn scar is a more effective method for improving the appearance of scars than the current available treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

9 months

First QC Date

August 29, 2009

Last Update Submit

July 24, 2011

Conditions

Scars

Keywords

burn scarfractional carbon dioxide laserscar revision

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings.

    2 weeks after each procedure

Study Arms (2)

Laser treatment

EXPERIMENTAL

Half of each subject's scar will be treated with a fractional CO2 laser.

Device: Lumenis fractional carbon dioxide laser

No treatment

NO INTERVENTION

Half of each subject's scar will not be treated.

Interventions

Lumenis fractional carbon dioxide laserDEVICE

Laser resurfacing of a burn scar

Also known as: Lumenis
Laser treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a mature burn scar and desire revision
  • Fluent in English
  • Must reside in the Los Angeles vicinity for the duration of the study

You may not qualify if:

  • Previous history of scar revision
  • Non-English speakers
  • Pregnant or cognitively impaired subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moy-Fincher Medical Group

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Ozog, MD

    Moy-Fincher Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 29, 2009

First Posted

September 1, 2009

Study Start

December 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

US(1)