At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 107 enrolled
Drug / intervention
rapamycin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2/3, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Response Comparison of the Efficacy and Safety of a Topical Rapamycin Cream for the Treatment of Facial Angiofibromas (FA) Associated With Tuberous Sclerosis Complex (TSC) in Patients 6 Years of Age and Over
In Brief
A Phase 3 clinical trial evaluating rapamycin and placebo for Facial Angiofibroma and Tuberous Sclerosis. Completed, enrolled 107 participants across 17 sites in 9 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Angiofibroma, Tuberous Sclerosis
CountriesAustralia, Czechia, Hungary, New Zealand, Serbia, Slovakia, Spain, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartJul 2019
Primary CompletionSep 2022
TodayJul 2026
First PostedFeb 1, 2019
Enrollment StartJul 28, 2019
Primary CompletionSep 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.4 years ago
Interventions
rapamycindrug
Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks
placebodrug
Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks