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RAPA-Keloid Study of Keloid Regression

NCT04049552 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-09-29

Study results available
· View outcomes & findings →

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

Conditions

  • Keloid

Interventions

DRUG

Rapamycin 8% Ointment

A compounded ointment containing 8% rapamycin

DRUG

Placebo

Petrolatum ointment placebo

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Dean L Kellogg Jr, MD · UT Health San Antonio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-24
Primary Completion
2020-08-24
Completion
2021-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049552 on ClinicalTrials.gov