Spots Global Cancer Trial Database for Topical Everolimus in Patients With Tuberous Sclerosis Complex
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Trial Identification
Brief Title: Topical Everolimus in Patients With Tuberous Sclerosis Complex
Official Title: Topical Everolimus Versus Placebo for the Treatment of Facial Angiofibromas in Patients With Tuberous Sclerosis Complex. A Phase II/III, Multicentre, Randomized, Double-blind, Placebo-controlled Study of 3 Doses of Topical Everolimus.
Study ID: NCT02860494
Conditions
Study Description
Brief Summary: Tuberous sclerosis complex (TSC) is a rare genetic multisystem disorder characterized by the development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and skin in more than 90% of cases. Facial angiofibromas (FA), present in about 80% of patients, are a stigmatizing hallmark of the disease. Everolimus could be a candidate for use as a topical formulation to treat FA. This adaptive seamless Phase II/III study primary objective is to determine the dose of topical everolimus for treatment of FA and evaluate the efficacy and safety of topical everolimus versus placebo in patients with angiofibromas.
Detailed Description:
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Hopital Femme Mère Enfant, Bron, , France
Contact Details
Name: Alice PHAN, MD
Affiliation: Hospices Civils de Lyon
Role: PRINCIPAL_INVESTIGATOR
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