Status:
COMPLETED
RAPA-Keloid Study of Keloid Regression
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Keloid
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
1. To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months) 2. To test safety of product and feasibility ...
Detailed Description
This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body ...
Eligibility Criteria
Inclusion
- Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
- Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
- Cognitive functioning sufficient to provide informed consent
- Physically able to apply ointment to keloids daily
- Able to attend monthly clinic visits for 6 months
Exclusion
- Diagnosis of diabetes
- Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
- Local area steroidal treatment within the past 3 months
- History of allergy to rapamycin of petrolatum-based products
Key Trial Info
Start Date :
January 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2021
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04049552
Start Date
January 24 2020
End Date
May 2 2021
Last Update
September 29 2021
Active Locations (1)
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1
Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, United States, 78229