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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

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

ArmDescriptionAssigned Intervention
Experimental
RAPA intervention 		Rapamycin ointment will be applied to one keloid on the subject
  • Drug: Rapamycin 8% Ointment
    A compounded ointment containing 8% rapamycin
    Other names:
    • Rapamycin ointment
Placebo Comparator
Placebo 		Placebo will be applied as a control on one keloid on the subject
  • Drug: Placebo
    Petrolatum ointment placebo
    Other names:
    • Petrolatum ointment

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.