Clinical trial NCT04049552: RAPA-Keloid Study of Keloid Regression
Official title: Effect of Topical Rapamycin Ointment on Keloid Regression: A Pilot Study in Human Subjects (RAPA-Keloid)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Keloid
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Study participants will serve as their own control, using intervention on one keloid and placebo on the other
Primary purpose: TREATMENT

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 of conduct for future clinical trial

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Keloid Surface Area
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Keloid Height
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Audie L Murphy Memorial Veterans Hospital
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Dean L Kellogg Jr, MD
role: PRINCIPAL_INVESTIGATOR
References: