RAPA-Keloid Study of Keloid Regression

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

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

Study Overview

• Status: Completed
• Conditions: Keloid
• Intervention / Treatment: Drug: Rapamycin 8% Ointment; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Audie L Murphy Memorial Veterans Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Dean L Kellogg Jr, MD, UT Health San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): August 24, 2020
• Study Completion (Actual): May 2, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Emollients; Sirolimus; Petrolatum
• Other Study ID Numbers: HSC20190291H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No