RAPA-Keloid Study of Keloid Regression

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.

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