RAPA-Keloid Study of Keloid Regression

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049552
• Other study ID #: HSC20190291H
• Status: Completed
• Phase: Early Phase 1
• Start date: January 24, 2020
• Est. completion date: May 2, 2021

Study information

• Verified date: September 2021
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 2, 2021
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Keloid

Intervention

Drug:
• Rapamycin 8% Ointment
A compounded ointment containing 8% rapamycin
• Placebo
Petrolatum ointment placebo

Locations

Country	Name	City	State
United States	Audie L Murphy Memorial Veterans Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Keloid Surface Area	Measurement of surface area of keloid	Baseline to 6 months
Secondary	Change in Keloid Height	Measurement of height of keloid	Baseline to 6 months