Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
4 participants
INTERVENTIONAL
2020-01-24
2021-05-02
Brief Summary
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2. To test safety of product and feasibility of conduct for future clinical trial
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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RAPA intervention
Rapamycin ointment will be applied to one keloid on the subject
Rapamycin 8% Ointment
A compounded ointment containing 8% rapamycin
Placebo
Placebo will be applied as a control on one keloid on the subject
Placebo
Petrolatum ointment placebo
Interventions
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Rapamycin 8% Ointment
A compounded ointment containing 8% rapamycin
Placebo
Petrolatum ointment placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Dean L Kellogg Jr, MD
Role: PRINCIPAL_INVESTIGATOR
UT Health San Antonio
Locations
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Audie L Murphy Memorial Veterans Hospital
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HSC20190291H
Identifier Type: -
Identifier Source: org_study_id
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