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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAPA intervention | Experimental | Rapamycin ointment will be applied to one keloid on the subject |
|
| Placebo | Placebo Comparator | Placebo will be applied as a control on one keloid on the subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin 8% Ointment | Drug | A compounded ointment containing 8% rapamycin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Keloid Surface Area | Measurement of surface area of keloid | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Keloid Height | Measurement of height of keloid | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dean L Kellogg Jr, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Audie L Murphy Memorial Veterans Hospital | San Antonio | Texas | 78229 | United States |
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Each subject enrolled was used as both active intervention and placebo, using 2 keloids on the same subject, color coded to have either rapamycin ointment or placebo ointment applied.
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Participants | Rapamycin ointment will be applied to one keloid on the subject, and placebo will be applied to the second keloid on that subject. Keloids will be color coded to match either rapamycin ointment or placebo. Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants, each with 2 keloids, served as their own control, with one keloid color coded for active drug and the other for placebo
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | Rapamycin ointment will be applied to one keloid on the subject and placebo will be applied to a second keloid. Keloids will be color coded to match ointment applied Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Keloid Surface Area | Measurement of surface area of keloid | Posted | Mean | Full Range | cm2 | Baseline to 6 months | keloids | keloids |
|
|
Baseline to 6 months.
Any study related adverse event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RAPA Intervention | Rapamycin ointment will be applied to one keloid on the subject Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dean L Kellogg Jr. | UT Health San Antonio | 210-617-5311 | kelloggd@uthscsa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2020 | Nov 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
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Study participants will serve as their own control, using intervention on one keloid and placebo on the other
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| Placebo | Drug | Petrolatum ointment placebo |
|
|
| Keloids |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Counts |
|---|
| Participants |
|
| keloids |
|
|
| Secondary | Change in Keloid Height | Measurement of height of keloid | Posted | Mean | Full Range | millimeters | Baseline to 6 months | keloids | keloids |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Placebo | Placebo will be applied as a control on one keloid on the subject Placebo: Petrolatum ointment placebo | 0 | 3 | 0 | 3 | 0 | 3 |
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| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004364 |
| Pharmaceutical Preparations |