RAPA-Keloid Study of Keloid Regression

Study Overview
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Brief Summary
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To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months) To test safety of product and feasibility of conduct for future clinical trial

Detailed Description
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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.

Official Title
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Effect of Topical Rapamycin Ointment on Keloid Regression: A Pilot Study in Human Subjects (RAPA-Keloid)

Conditions
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Keloid

Intervention / Treatment
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* Drug: Rapamycin 8% Ointment
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Study participants will serve as their own control, using intervention on one keloid and placebo on the other
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RAPA intervention<br>Rapamycin ointment will be applied to one keloid on the subject | Drug: Rapamycin 8% Ointment<br>* A compounded ointment containing 8% rapamycin<br>* Other names: Rapamycin ointment;|
| Placebo Comparator: Placebo<br>Placebo will be applied as a control on one keloid on the subject | Drug: Placebo<br>* Petrolatum ointment placebo<br>* Other names: Petrolatum ointment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Keloid Surface Area | Measurement of surface area of keloid | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Keloid Height | Measurement of height of keloid | Baseline to 6 months |