CompletedPhase 1

Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream

United States11 participantsStarted 2013-10

Plain-language summary

The objective of this study is to evaluate the safety and efficacy of a 0.1% formulation of rapamune cream in children with Tuberous Sclerosis Complex (TSC), ages 3 years and older, who have facial angiofibromas that would benefit from treatment.

Who can participate

Age range3 Years – 45 Years

SexALL

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Inclusion criteria

✓. Patient must have a diagnosis of Tuberous Sclerosis Complex.
✓. Female or male patients over the age of 3 years.
✓. Female subjects of child bearing potential must not be pregnant and must undergo a pregnancy test, and must agree to use appropriate contraceptive methods

Exclusion criteria

✕. Patient has a history of drug allergy to rapamune.
✕. Patient is pregnant or lactating.
✕. Subject is 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 investigative drug.
✕. 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.

What they're measuring

Reduction of facial angiofibroma with use of rapamune facial skin cream

Timeframe: 1 year

Trial details

NCT IDNCT01853423

SponsorLe Bonheur Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Facial Angiofibroma trials