Clinical trial · Interventional
Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)
A Randomized, Double-blind, Vehicle-controlled, Multicenter Trial of Topically Administered LDE225 Cream (0.75% Bid) to Evaluate Clearance of Basal Cell Carcinoma in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDE225B | Drug | — | UNRESOLVED |
| Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- LDE225 0.75% cream
- interventionNames
- Drug: LDE225B
- type
- PLACEBO_COMPARATOR
- label
- Vehicle
- interventionNames
- Drug: Vehicle
Primary outcomes (1)
- measure
- 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
- timeFrame
- 4 weeks after LDE225 treatment
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult greater than 18 years old, male or female. 2. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study. 3. Typical presentation of NBCCS in the opinion of the investigator 4. At least one of the major clinical criteria of NBCCS. 5. Multiple BCCs during the screening period Exclusion Criteria: 1. Any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator. 2. Prior exposure to LDE225. 3. Use of systemic treatment for BCC in the 4 weeks prior to Baseline. 4. Use of topical treatment or photodynamic therapy (PDT) in the 12 weeks prior to Baseline. 5. Use of other investigational drugs at Baseline, or within 30 days or 5 half-lives prior to Baseline, whichever is longer. 6. Clinically significant medical condition, as per judgment of the investigator. 7. History of hypersensitivity to any of the ingredient of the study drug. 8. Pregnant or nursing (lactating) women 9. Women of child-bearing potential and fertile males, UNLESS they are using two birth control methods Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available