Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Facial Angiofibroma, Tuberous Sclerosis
In brief
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).
Key facts
- Study ID
- NCT03826628
- Run by
- Dermatology Specialties Limited Partnership
- People needed
- 107
- Starts
- 2019-07-28
- Expected to finish
- 2022-09-01
- Last updated by the study team
- 2023-09-08
Who can join
Age: 6 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Patients judged unsuitable for this clinical trial by the investigator or sub-investigator
- Pregnant or lactating females
- Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
- Patients with immune dysfunction or receiving any form of immunosuppression
- Patients with severe FA, with a score of 4 on the IGA scale
- Patients with an FA severity score of less than 2 on the IGA scale
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- University of California San Diego — La Jolla, California, United States
- All Children's Research Institute — St. Petersburg, Florida, United States
- Spectrum Health — Grand Rapids, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University of Virginia — Charlottesville, Virginia, United States
- Children's Health Queensland — Brisbane, Queensland, Australia
- Fakultni nemocnice Brno — Brno, Czechia
- Bethesda Children's Hospital of the Hungarian Reformed Church — Budapest, Hungary
- University of Pécs — Pécs, Hungary
- Canterbury District Health Board — Christchurch, Canterbury, New Zealand
- Clinic of Neurology and Psychiatry for Children and Youth — Belgrade, Serbia
- Clinical Center of Serbia — Belgrade, Serbia
- Narodný ústav detských chorȏb — Bratislava, Slovakia
- Clinica Universidad de Navarra — Pamplona, Navarre, Spain
- Clínica Universidad de Navarra — Madrid, Spain
- National Taiwan University Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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