Status:
WITHDRAWN
Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hypertrophic Scars
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This project aims to understand the molecular biology underlying the improvement of surgical scars treated by ablative fractional photothermolysis (FP). Previous human studies at MGH have shown that F...
Detailed Description
A prospective, open-label study in 10 healthy adults, ages 18-50, with abdominal scars will be pursued at the Clinical Research Unit at Wellman Center for Photomedicine (MGH). A side-by-side compariso...
Eligibility Criteria
Inclusion
- Subjects who are healthy with ages between 18 and 50 years.
- Subjects who have had their most recent abdominal procedure at least 2 years prior to enrollment in study.
- Subjects with surgical scars with a length greater than 10 cm or 4 inches.
- Subjects whose scars are either hypertrophic or atrophic but enlarged.
- Subjects who are willing to participate in the study.
- Subjects who are willing to receive laser treatment.
- Subjects who are willing to receive skin biopsies.
- Subjects who agree and sign an informed consent relating to study procedures.
- Subjects who are willing to follow the treatment schedule and post-treatment care requirements.
- Subjects who had not received any topical treatment for scars in the past month, including corticosteroid injections, topical fluorinated corticosteroids or any other laser treatment.
- Subjects who are willing to avoid topical or systemic scar treatment, including topical over-the-counter (OTC) corticosteroids, during the study period.
Exclusion
- Subjects with underlying skin or other medical conditions that could have an adverse effect on wound healing.
- Subjects with evidence of infection on area to be treated or elsewhere on body.
- Subjects with presence of suntan in the area to be treated.
- Subjects who have had topical/Injected corticosteroids within 1 month of entering the study.
- Subjects with known anticoagulation or thromboembolic condition.
- Subjects who are immunosuppressed.
- Subjects who are unable to comply with treatment, home care, or follow-up visits.
- Subjects who are pregnant or breast-feeding.
- Subjects with known autoimmune disease.
- Subjects who are enrolled in any other clinical trial using systemic medication; or any other treatment that might interfere with this study.
- Subjects with known diabetes mellitus
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Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01858038
Start Date
May 1 2013
End Date
December 1 2014
Last Update
September 19 2019
Active Locations (1)
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1
Massachusetts General Hospital - Wellman Center for Photomedicine
Boston, Massachusetts, United States, 02114