Clinical trial · Interventional
To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)
Double-blind, Randomized, Vehicle-controlled Proof of Concept Study on the Efficacy, Safety, Local Tolerability, PK and Pharmacodynamics of Multiple Topical Administrations of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The data from participants with sBCCs showed insufficient efficacy with current formulation and treatment conditions.
Summary
Brief summary (as posted)
This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post treatment biopsies, as safety visit one week after final study drug administration (Day 50), a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).
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 |
|---|---|---|---|
| Sporadic Superficial and Nodular Skin Basal Cell Carcinomas | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LDE225 0.75% | Drug | Sonidegib | ALIAS |
| Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LDE225 0.75%
- description
- Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
- interventionNames
- Drug: LDE225 0.75%
- type
- PLACEBO_COMPARATOR
- label
- Vehicle
- description
- Participants topically applied matching placebo cream twice daily for 6 weeks.
- interventionNames
- Drug: Vehicle
Primary outcomes (1)
- measure
- Clinical Evaluation of sBCCs Tumors
- timeFrame
- Day 43
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with one histologically confirmed superficial and nodular basal cell carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp, arm, frontal trunk, posterior trunk, upper legs) Exclusion Criteria: * Previous treatment of the sBCC that are selected for treatment. * Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments. * Dark-skinned persons whose skin color prevents readily assessment of skin reactions Other protocol defined Incl./Excl. criteria may apply.
References
Publications (0)
Data not yet available