A 1-year Study of Topical Application of a Gel Containing the Investigational Active Ingredient Patidegib versus the same Gel Without Patidegib (Placebo) for the Prevention of New Facial Skin Tumors (Basal Cell Carcinomas) in People with Gorlin Syndrome

Phase 1

• Conditions: Basal Cell Nevus Syndrome; MedDRA version: 20.1Level: LLTClassification code 10004151Term: Basal cell nevus syndromeSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2018-001462-42-BE
• Lead Sponsor: PellePharm, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Key
1. The subject must be at least 18 years old at the Screening visit.
2. The subject must meet diagnostic criteria for Gorlin syndrome (Inclusion Criteria 3).
3. The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter <5 mm present on the face prior to randomization.
4. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Key
1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
2. The subject is known to have a hypersensitivity to any of the ingredients in the IP.
3. The subject has uncontrolled systemic disease.
4. 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified