Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    kellogg | effects of rapamycin ointment
Previous Study | Return to List | Next Study

RAPA-Keloid Study of Keloid Regression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049552
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief 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

Condition or disease Intervention/treatment Phase
Keloid Drug: Rapamycin 8% Ointment Drug: Placebo Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Study participants will serve as their own control, using intervention on one keloid and placebo on the other
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Topical Rapamycin Ointment on Keloid Regression: A Pilot Study in Human Subjects (RAPA-Keloid)
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


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 Name: Rapamycin ointment

Placebo Comparator: Placebo
Placebo will be applied as a control on one keloid on the subject
Drug: Placebo
Petrolatum ointment placebo
Other Name: Petrolatum ointment




Primary Outcome Measures :
  1. Change in Keloid Surface Area [ Time Frame: Baseline to 6 months ]
    Measurement of surface area of keloid


Secondary Outcome Measures :
  1. Change in Keloid Height [ Time Frame: Baseline to 6 months ]
    Measurement of height of keloid



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 sterioidal treatment within the past 3 months
  • History of allergy to rapamycin of petrolatum-based products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049552


Contacts
Layout table for location contacts
Contact: Dean L Kellogg, Jr, MD 210-617-5197 kelloggd@uthscsa.edu
Contact: Terry Romo, FNP-BC 210-949-3706 romot@uthscsa.edu

Locations
Layout table for location information
United States, Texas
Audie L Murphy Memorial Veterans Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: Terri Romo, FNP-BC    210-949-3706    romot@uthscsa.edu   
Contact: Beth Wu, BS    210-617-5300 ext 15558    wuy3@uthscsa.edu   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Layout table for investigator information
Principal Investigator: Dean L Kellogg Jr, MD UT Health San Antonio

Layout table for additonal information
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT04049552    
Other Study ID Numbers: HSC20190291H
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Sirolimus
Everolimus
Petrolatum
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Emollients
Dermatologic Agents