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RAPA-Keloid Study of Keloid Regression

Primary Purpose

Keloid

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rapamycin 8% Ointment

Placebo

About this trial

This is an interventional treatment trial for Keloid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Audie L Murphy Memorial Veterans Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RAPA intervention

Placebo

Arm Description

Rapamycin ointment will be applied to one keloid on the subject

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

Outcomes

Primary Outcome Measures

Change in Keloid Surface Area

Measurement of surface area of keloid

Secondary Outcome Measures

Change in Keloid Height

Measurement of height of keloid

Full Information

NCT ID

NCT04049552

First Posted

August 6, 2019

Last Updated

September 1, 2021

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT04049552

Brief Title

RAPA-Keloid Study of Keloid Regression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

January 24, 2020 (Actual)

Primary Completion Date

August 24, 2020 (Actual)

Study Completion Date

May 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keloid

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

Participant

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RAPA intervention

Arm Type

Experimental

Arm Description

Rapamycin ointment will be applied to one keloid on the subject

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rapamycin 8% Ointment

Other Intervention Name(s)

Rapamycin ointment

Intervention Description

A compounded ointment containing 8% rapamycin

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Petrolatum ointment

Intervention Description

Petrolatum ointment placebo

Primary Outcome Measure Information:

Title

Change in Keloid Surface Area

Description

Measurement of surface area of keloid

Time Frame

Baseline to 6 months

Secondary Outcome Measure Information:

Title

Change in Keloid Height

Description

Measurement of height of keloid

Time Frame

Baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dean L Kellogg Jr, MD

Organizational Affiliation

UT Health San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

Audie L Murphy Memorial Veterans Hospital

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

RAPA-Keloid Study of Keloid Regression

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