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Clinical Trials/2023-507528-21-00
2023-507528-21-00RecruitingPhase 3

A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Gel 2% for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Gorlin Syndrome

Sol-Gel Technologies Ltd.14 sites in 6 countries60 target enrollmentStarted: April 11, 2024Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
60
Locations
14
Primary Endpoint
Number of new BCCs at Month 12 in the 2 arms (Patidegib Gel 2% and vehicle) when applied twice daily to the face of subjects with Gorlin syndrome as assessed by the CPRB
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To assess the efficacy of Patidegib Gel 2% when applied twice daily to the face of subjects with Gorlin syndrome

Study Design

Allocation
Not Applicable
Primary Purpose
Remote safety follow-up Visit
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •The subject must be at least 18 years old at the Screening Visit
  • •The subject must be confirmed to have a PTCH1 mutation
  • •The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1)
  • •The subject must be willing to abstain from application of any non-study topical medication (prescription or over the counter) to their facial skin for the duration of the trial, except as prescribed by the investigator

Exclusion Criteria

  • •The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study Investigational Product (IP)
  • •The subject is known to have hypersensitivity to any of the ingredients in the IP formulation
  • •The subject has uncontrolled systemic disease
  • •The subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia Stage 0 and non-melanoma skin cancer, Stage I cervical cancer, or ductal carcinoma in situ of the breast
  • •Previous Hedgehog inhibitor therapy was considered to have failed for reasons other than unfavorable side effect(s)

Outcomes

Primary Outcomes

Number of new BCCs at Month 12 in the 2 arms (Patidegib Gel 2% and vehicle) when applied twice daily to the face of subjects with Gorlin syndrome as assessed by the CPRB

Number of new BCCs at Month 12 in the 2 arms (Patidegib Gel 2% and vehicle) when applied twice daily to the face of subjects with Gorlin syndrome as assessed by the CPRB

Secondary Outcomes

  • Number of New Surgically Eligible BCCs (nSEBs) at Month 12 in the 2 arms (Patidegib Gel 2% and vehicle) when applied twice daily to the face of subjects with Gorlin syndrome
  • Change from Baseline to Month 12 in Advanced Basal Cell Carcinoma Index (aBCCdex) lesion symptoms scale score
  • Change from Baseline to Month 12 in confirmed BCCs lesion diameter
  • Proportion of Surgically Eligible BCCs (SEBs) and nSEBs assessed as resolved by Month 12
  • Proportion of SEBs and nSEBs per subject that have regressed by Month 12
  • Proportion of subjects developing ≥2 facial new BCCs at Month 12
  • Change in total number of confirmed BCCs from Baseline to Month 12
  • Change from Baseline to Month 12 in the Skin Cancer Index quality of life questionnaire score
  • Adverse events (AEs), including serious adverse events (SAEs) occurring at any time during the study
  • Investigator Dermal Safety and Local Tolerability Assessments score at any time during the study
  • Change from Baseline to Month 12 in Patient Global Impression in disease Severity (PGI-S)
  • Change in Patient Global Impression of Change in clinical status (PGI C) at Month 12
  • Number of new BCCs at Month 12 in the 2 arms (Patidegib Gel 2% and vehicle) when applied twice daily to the face of subjects with Gorlin syndrome
  • Number of nSEBs at Month 12 in the 2 arms (Patidegib Gel 2% and vehicle) when applied twice daily to the face of subjects with Gorlin syndrome
  • Time to first new BCC
  • Skin pain and peak pruritus scores as reported by the subject on a numeric rating scale

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Clinical team member

Scientific

Sol-Gel Technologies Ltd.

Study Sites (14)

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