RAPA-Keloid Study of Keloid Regression
Purpose
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 of conduct for future clinical trial
Condition
- Keloid
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Study participants will serve as their own control, using intervention on one keloid and placebo on the other
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental RAPA intervention |
Rapamycin ointment will be applied to one keloid on the subject |
|
Placebo Comparator Placebo |
Placebo will be applied as a control on one keloid on the subject |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center at San Antonio
Study Contact
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 regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses. Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37). Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.