Status:
COMPLETED
Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.
Lead Sponsor:
The Metis Foundation
Collaborating Sponsors:
United States Army Institute of Surgical Research
Conditions:
Hypertrophic Scar
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked...
Eligibility Criteria
Inclusion
- Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser.
- Timing: There has been a minimum of 1 month after burn closure
- The subject is at least 18 years of age and not older than 65.
- Able and willing to provide verbal and written consent.
Exclusion
- Active infection in experimental area
- Use of isotretinoin (Accutane) in last six months
- Life or limb-threatening injury/disease
- Prior history of non-compliance with medical regimes
- Active drug use/abuse
- Active psychiatric illness except depression (unless being treated for suicidal intentions)
- Pregnancy
- Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment.
- Prior PDL or other laser treatment of the study area.
- Patient unable to tolerate laser procedure.
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04769089
Start Date
December 19 2017
End Date
June 24 2020
Last Update
February 24 2021
Active Locations (1)
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1
United States Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234