RAPA-Keloid Study of Keloid Regression

NCT04049552 | Completed Early Phase 1 Results DMC FDA Drug

• 1 other identifier: HSC20190291H
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To test safety of product and feasibility of conduct for future clinical trial

Conditions

Keloid

Outcome Measures

Primary Outcomes (1)

• Change in Keloid Surface Area

  Measurement of surface area of keloid

  Baseline to 6 months

Secondary Outcomes (1)

• Change in Keloid Height

  Baseline to 6 months

Study Arms (2)

RAPA intervention

EXPERIMENTAL

Rapamycin ointment will be applied to one keloid on the subject

Drug: Rapamycin 8% Ointment

Placebo

PLACEBO COMPARATOR

Placebo will be applied as a control on one keloid on the subject

Drug: Placebo

Interventions

Rapamycin 8% Ointment DRUG

A compounded ointment containing 8% rapamycin

Also known as: Rapamycin ointment

RAPA intervention

Placebo DRUG

Petrolatum ointment placebo

Also known as: Petrolatum ointment

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Audie L Murphy Memorial Veterans Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Keloid

Interventions

Sirolimus; Ointments

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dean L Kellogg Jr.
• Organization: UT Health San Antonio

kelloggd@uthscsa.edu

210-617-5311

Study Officials

• Dean L Kellogg Jr, MD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will serve as their own control, using intervention on one keloid and placebo on the other

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: January 24, 2020
• Primary Completion: August 24, 2020
• Study Completion: May 2, 2021
• Last Updated: September 29, 2021
• Results First Posted: December 28, 2020

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)