Status:
COMPLETED
Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex
Lead Sponsor:
Dermatology Specialties Limited Partnership
Conditions:
Facial Angiofibroma
Tuberous Sclerosis
Eligibility:
All Genders
6-65 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Topical rapamycin has previously been used to treat FA associated with TSC, reducing erythema, papule size, while flattening lesions and improving skin texture. Topical rapamycin has been reported to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT03826628
Start Date
July 28 2019
End Date
September 1 2022
Last Update
September 8 2023
Active Locations (17)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
University of California San Diego
La Jolla, California, United States, 92037
3
All Children's Research Institute
St. Petersburg, Florida, United States, 33701
4
Spectrum Health
Grand Rapids, Michigan, United States, 49503