Early Phase 1
N=4
RAPA-Keloid Study of Keloid Regression
Keloid
Bottom Line
View on ClinicalTrials.gov: NCT04049552 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Change in Keloid Surface Area — 0.455; -0.039 cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Rapamycin 8% Ointment (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Keloid Surface Area |
0.455; -0.039 | — |
| SECONDARY Change in Keloid Height |
1.5; 1.55; 1.056; 0.93 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT04049552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.