Topical Rapamycin to Erase Angiofibromas in TSC
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/3/2014 |
| Start Date: | May 2012 |
| End Date: | August 2014 |
| Contact: | Patti L Tate, RCP, CCRP |
| Email: | patti.l.tate@uth.tmc.edu |
| Phone: | 713-500-5659 |
Phase II Study of Topical Rapamycin to Erase Angiofibromas in TSC-Multicenter Evaluation of a Novel Therapy
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 in subjects with Tuberous Sclerosis Complex (TSC). Subjects will
apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly
to their angiofibromas for six months.
The primary goal of this study is to evaluate the efficacy of the topical medication for
reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study
is to confirm the safety of the topical medication.
evaluation of the safety and efficacy of a topically applied formulation of rapamycin to
cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will
apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly
to their angiofibromas for six months.
The primary goal of this study is to evaluate the efficacy of the topical medication for
reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study
is to confirm the safety of the topical medication.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
9
sites
Boston, Massachusetts 02114
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Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Oakland, California 94609
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