Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associa… (NCT03826628) | Clinical Trial Compass
CompletedPhase 2/3
Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
United States107 participantsStarted 2019-07-28
Plain-language summary
The study aims to compare the safety and efficacy of two different strengths of Rapamycin cream, topical and placebo over 26 weeks in the treatment of facial angiofibroma (FA) associated with Tuberous Sclerosis Complex (TSC).
Who can participate
Age range6 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged ≥ 6 years and ≤ 65 years on the day informed consent is obtained
✓. Patients diagnosed with TSC based on the clinical diagnostic criteria of International Tuberous Sclerosis Complex Consensus Conference 2012 and presenting visible facial angiofibroma
✓. An FA severity score of 2 or 3 on the IGA scale
✓. Patients or their legal representatives capable of understanding the explanation of the clinical trial and who give written informed consent for participation
✓. Patients or their legal representatives able to maintain patient diaries following the instructions of the investigator or sub-investigator
Exclusion criteria
✕. Patients who cannot carry out the treatment plan or follow-up assessment
✕. Patients with serious skin lesions such as erosions or ulcers
✕. Patients with known hypersensitivity to any component of the study product
✕. Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment
✕. Patients who received laser therapy or surgical therapy within 6 months prior to trial enrolment
✕. Patients who participated in any other clinical trial within 3 months prior to the day of enrolment
✕
What they're measuring
1
Percentage of Participants Obtaining Successful Treatment