Topical Rapamycin to Erase Angiofibromas in TSC

Completed · Phase 2 · Has a placebo group

Conditions studied: Angiofibromas, Tuberous Sclerosis

In brief

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.

Key facts

Study ID

NCT01526356

Run by

The University of Texas Health Science Center, Houston

People needed

179

Starts

2012-05-01

Expected to finish

2014-08-01

Last updated by the study team

2020-10-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 .

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UCLA Mattel Children's Hospital — Los Angeles, California, United States
• Jack & Julia Center for TSC at Oakland Children's Hospital & Research Center — Oakland, California, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Herscot Center for Adults and Children with TSC Massachusetts General Hospital — Boston, Massachusetts, United States
• Clinic Without Walls — Saint Paul, Minnesota, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Texas Scottish Rite Hospital — Dallas, Texas, United States
• The University of Texas Medical School at Houston — Houston, Texas, United States
• Sydney Children's Hospital — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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