RAPA-Keloid Study of Keloid Regression

Early Phase 1

Completed

• Conditions: Keloid
• Interventions: Drug: Placebo; Drug: Rapamycin 8% Ointment

• Registration Number: NCT04049552
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-08
• Study Start: 2020-01-24
• Primary Completion: 2020-08-24
• Results First Submitted: 2020-11-10
• Results First Submitted QC: 2020-12-02
• Results First Posted: 2020-12-28
• Study Completion: 2021-05-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo will be applied as a control on one keloid on the subject
RAPA intervention	Rapamycin 8% Ointment	Rapamycin ointment will be applied to one keloid on the subject

Primary Outcome Measures

Name	Time	Method
Change in Keloid Surface Area	Baseline to 6 months	Measurement of surface area of keloid

Secondary Outcome Measures

Name	Time	Method
Change in Keloid Height	Baseline to 6 months	Measurement of height of keloid

Trial Locations

Locations (1)

Audie L Murphy Memorial Veterans Hospital; 🇺🇸 San Antonio, Texas, United States