Fractional Nonablative 1540 nm Laser Resurfacing for Burn... | NCT00689650

Studies
Fractional Nonablative 1540 nm Laser Resurfacing for Burn Scars- A Randomised Controlled Trial

NCT00689650

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Jun 3, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Burn Scar Patients

Interventions

1540 nm fractional 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

Status Module

Record Verification Date

May 2008

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 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 30, 2008

First Submission Date that Met QC Criteria

May 30, 2008

First Posted Date

Jun 3, 2008Estimated

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

May 30, 2008

Last Update Posted Date

Jun 3, 2008Estimated

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
A	Experimental		Device: 1540 nm fractional laser
B	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
1540 nm fractional laser	Device		A

Measure	Description	Time Frame
Change of skin texture from baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Burn scars with and without previous skin grafting.

Exclusion Criteria:

A tendency to produce hypertrophic scars or keloids,
Previous treatment with dermabrasio, chemical peel, filler, laser treatment or Intense Pulsed Light (IPL) of study areas,
Photosensitivity,
Pregnancy or lactation,
Current anticoagulative medication,
Oral retinoid drugs within the past 6 months,
Pigmentation after recent exposure to sun or solarium,
Patients not considered to be able to follow the treatment protocol.

Accepts Healthy Volunteers

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg University Hospital		Copenhagen NV		2400	Denmark