Phase 2/3Completed

Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

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

Sponsor
Dermatology Specialties Limited Partnership (Industry)
Enrolment
107 enrolled
Conditions
Facial Angiofibroma; Tuberous Sclerosis
Interventions
rapamycin; placebo
Ages
children, adults, older adults
Registry
NCT03826628

Full record on ClinicalTrials.gov

From the registry

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).

Primary outcomes

  • Percentage of Participants Obtaining Successful Treatment

History

  1. Last registry update

  2. Results first posted

  3. Primary completion

  4. Started

  5. Registered