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This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete clinical clearance and complete histological clearance in BCCs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDE225 0.75% cream | Active Comparator |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDE225B | Drug | Cream, 2x daily |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate superiority of topical LDE225 versus vehicle in terms of treatment success in patients with NBCCs. Measure: Complete clinical clearance and complete histological clearance of BCCs | 4 weeks after LDE225 treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety of topical treatment with LDE225, compared to vehicle. Measure: Reported systemic adverse events in patients with NBCCS | Treatment phase and up to 4 weeks after LDE225 treatment | |
| To evaluate the local tolerability of topical treatment with LDE225, compared to vehicle. Measure:Reported local adverse events in patients with NBCCS |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Brussels | Belgium | ||||
| Novartis Investigative site |
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| Drug |
cream, 2x daily |
|
| Treatment phase and up to 4 weeks after LDE225 treatment |
| To assess the rate of complete clinical clearance of BCCs in patients with NBCCS. Measure: No clinical residual signs of carcinoma | 4 weeks after LDE225 treatment |
| To assess the rate of complete histological clearance of BCCs in patients with NBCCS. Measure: No residual tumor tissue | 4 weeks after LDE225 treatment |
| Leuven |
| Belgium |
| Novartis Investigative site | Waterloo | Ontario | Canada |
| Novartis Investigative site | Sainte-Foy | Quebec | Canada |
| Novartis Investigative site | Prague | Czechia |
| Novartis Investigative site | Helsinki | Finland |
| Novartis Investigative Site | Berlin | Germany |
| Novartis Investigative Site | Bonn | Germany |
| Novartis Investigative Site | Dresden | Germany |
| Novartis Investigative Site | Essen | Germany |
| Novartis Investigative Site | Frankfurt | Germany |
| Novartis Investigative Site | Heidelberg | Germany |
| Novartis Investigative Site | Jena | Germany |
| Novartis Investigative Site | Kiel | Germany |
| Novartis Investigative Site | Lübeck | Germany |
| Novartis Investigative Site | Mainz | Germany |
| Novartis Investigative Site | Munich | Germany |
| Novartis Investigative Site | Münster | Germany |
| Novartis Investigative Site | Recklinghausen | Germany |
| Novartis Investigative Site | Tübingen | Germany |
| Novartis Investigative Site | Würzburg | Germany |
| Novartis Investigative Site | Athens | Greece |
| Novartis Investigative site | Thessaloniki | Greece |
| Novartis Investigative site | Catania | Italy |
| Novartis Investigative site | L’Aquila | Italy |
| Novartis Investigative site | Naples | Italy |
| Novartis Investigative site | Padova | Italy |
| Novartis Investigative site | Siena | Italy |
| Novartis Investigative site | Barcelona | Spain |
| Novartis Investigative site | Madrid | Spain |
| Novartis Investigative site | Lausanne | Switzerland |
| Novartis Investigative site | Zurich | Switzerland |
| Novartis Investigative site | Glasgow | United Kingdom |
| Novartis Investigative site | London | United Kingdom |
| Novartis Investigative site | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D001478 | Basal Cell Nevus Syndrome |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
| D009807 | Odontogenic Cysts |
| D007570 | Jaw Cysts |
| D001845 | Bone Cysts |
| D003560 | Cysts |
| D009386 | Neoplastic Syndromes, Hereditary |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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