Clinical trial · Interventional
A Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC
A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients With Non-Gorlin High Frequency BCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated early due to low blinded event rate
Summary
Brief summary (as posted)
This is a multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs.
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 |
|---|---|---|---|
| Recurrent Basal Cell Carcinoma | Basal Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patidegib Topical Gel, 2% | Drug | Patidegib | ALIAS |
| Patidegib Topical Gel, Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patidegib Topical Gel, 2%
- description
- Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
- interventionNames
- Drug: Patidegib Topical Gel, 2%
- type
- ACTIVE_COMPARATOR
- label
- Patidegib Topical Gel, Vehicle
- description
- Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months
- interventionNames
- Drug: Patidegib Topical Gel, Vehicle
Primary outcomes (1)
- measure
- Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter \<5 mm present on the face prior to Screening and Randomization (Baseline/Day 1). 2. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Exclusion Criteria: 1. The subject has been previously diagnosed with Gorlin syndrome 2. On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome. 3. Patients with a family history of medulloblastoma 4. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP. 5. The subject has uncontrolled systemic disease. 6. The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.
References
Publications (0)
Data not yet available