Status:
COMPLETED
Topical Rapamycin to Erase Angiofibromas in TSC
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Angiofibromas
Tuberous Sclerosis
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas i...
Eligibility Criteria
Inclusion
- Subjects must be willing and able to comply with all trial requirements.
- Subject has a diagnosis of TSC and has visible facial angiofibromas.
- Female subjects of child bearing potential must not be pregnant and must agree to use appropriate contraceptive methods .
Exclusion
- Subject is currently receiving therapy with Rapamycin.
- Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction.
- Subject is currently participating in or has participated within the last 30 days in a clinical trial involving an investigational drug.
- Subject has a known hypersensitivity to either the vehicle or Rapamycin.
- Subject is a pregnant or nursing female.
- Subject has other dermatologic conditions that would preclude or prevent adequate assessment of changes to their facial angiofibromas.
- Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their facial angiofibromas within the previous 6 months.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01526356
Start Date
May 1 2012
End Date
August 1 2014
Last Update
October 26 2020
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UCLA Mattel Children's Hospital
Los Angeles, California, United States, 90095
3
Jack & Julia Center for TSC at Oakland Children's Hospital & Research Center
Oakland, California, United States, 94609
4
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205