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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial to Evaluate the Safety, Local Tolerability, Pharmacokinetics and Pharmacodynamics of LDE225 on Skin Basal Cell Carcinomas in Gorlin Syndrome Patients

NCT00961896

Treatment for Basal Cell Carcinomas (BCCs) in Gorlin Syndrome Patients

COMPLETED PHASE2

Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate

NCT03569345

Carcinoma, Basal Cell

COMPLETED PHASE1/PHASE2

Safety and Efficacy Study of AM001 Cream in the Treatment of Actinic Keratosis

NCT03210740

Actinic Keratosis

COMPLETED PHASE2

Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.

NCT00049959

Basal Cell Carcinoma Nevoid Basal Cell Carcinoma Syndrome Gorlin Syndrome

TERMINATED PHASE3

Fractional CO2 Laser Assisted Photodynamic Therapy

NCT01260987

Actinic Keratosis Basal Cell Carcinoma

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Basal Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LDE225 0.75% cream

Group Type ACTIVE_COMPARATOR

LDE225B

Intervention Type DRUG

Cream, 2x daily

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

cream, 2x daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LDE225B

Cream, 2x daily

Intervention Type DRUG

Vehicle

cream, 2x daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No