Burn Scar Appearance After Treatment With Fractional Carb... | NCT00969215

Studies
Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser

NCT00969215

Sponsor

Moy-Fincher Medical Group

Status

Completed

Last Update Posted

Jul 26, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Scars

Interventions

Lumenis fractional carbon dioxide laser

Countries

United States

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

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 29, 2009

First Submission Date that Met QC Criteria

Aug 31, 2009

First Posted Date

Sep 1, 2009Estimated

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

Jul 24, 2011

Last Update Posted Date

Jul 26, 2011Estimated

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

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.

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lumenis fractional carbon dioxide laser	Device	Laser resurfacing of a burn scar	Laser treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of clinical improvement of burn scar appearance as determined by blinded-observer and patient ratings.		2 weeks after each procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Ozog, MD	Moy-Fincher Medical Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Moy-Fincher Medical Group		Los Angeles	California	90095	United States

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided