WithdrawnPhase 2/3

Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

Belgium, Canada, Czechia0

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Adult greater than 18 years old, male or female.
✓. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
✓. Typical presentation of NBCCS in the opinion of the investigator
✓. At least one of the major clinical criteria of NBCCS.
✓. Multiple BCCs during the screening period

Exclusion criteria

✕. Any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator.
✕. Prior exposure to LDE225.
✕. Use of systemic treatment for BCC in the 4 weeks prior to Baseline.
✕. Use of topical treatment or photodynamic therapy (PDT) in the 12 weeks prior to Baseline.
✕. Use of other investigational drugs at Baseline, or within 30 days or 5 half-lives prior to Baseline, whichever is longer.
✕. Clinically significant medical condition, as per judgment of the investigator.
✕. History of hypersensitivity to any of the ingredient of the study drug.
✕. Pregnant or nursing (lactating) women

What they're measuring

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

Trial details

NCT IDNCT03070691

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Basal Cell Carcinoma trials