PATIDEGIB study
Research type
Research Study
Full title
A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome
IRAS ID
246792
Contact name
Catherine Anne Harwood
Contact email
Sponsor organisation
PellePharm, Inc.
Eudract number
2018-001462-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Pro000028147, Canadian IRB Study Identifier
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
This is a global, multicentre, randomised, double-blind, stratified, vehicle-controlled Phase-3 study to test how effective and safe the Patidegib Topical Gel, 2%, is when applied topically twice daily to the face of adult participants with Basal Cell Nevus Syndrome (BCNS also known as Gorlin syndrome). Double-blind means neither the participant nor their study doctor will know which treatment participant is receiving.
About 150 participants will take part in this study at about 50 clinics in 10 countries. During the study, about 75 participants will receive a topical gel containing the active ingredient (patidegib 2%) and about 75 participants will receive a topical gel that does not contain the active ingredient (Vehicle or control) for comparison. In this document, “study gel” refers to both study treatments, Patidegib Topical Gel, 2%, and Vehicle. A vehicle controlled study is a study where the design is a controlled study against a vehicle (dermatological or topical product which is neither a drug nor a placebo).
The main purpose of this study is to see if the study gel, which is applied to the face, reduces the number of new surgically eligible Basal Cell Carcinomas (BCCs) and learn more about the safety of the study gel. This information will be obtained by taking samples of participants blood and urine, taking biopsies (tissue samples) of their skin and collection of images of their facial area .
The study includes 14 visits to the clinic (screening, enrollment, 13 treatment visits after enrollment [every 1 month]). A safety follow-up (by phone) will occur about 30 days after participants complete or withdraw from the study.
This study would last 13 (12 month treatment period + 30 day follow up period) months, excluding the screening visit. The screening visit will occur no more than 45 days before first application of study gel at the enrollment visit. A safety follow-up phone call will occur about 30 days after participants either complete or withdraw from the study.REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0455
Date of REC Opinion
14 May 2019
REC opinion
Further Information Favourable Opinion