Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

May 29, 2023 updated by: Sol-Gel Technologies, Ltd.

A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)

This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • PellePhram Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-2400
        • PellePharm Investigative Site
  • France
      • Lille, France
        • PellePharm Investigative Site
      • Nantes, France, 44093
        • PellePharm Investigative Site
      • Paris, France, 75010
        • Hopital Saint Louis
  • Germany
      • Berlin, Germany, 10117
        • PellePharm Investigative Site
      • Munich, Germany, 80337
        • PellePharm Investigative Site
      • Münster, Germany, 48149
        • PellePharm Investigative Site
  • Italy
      • Napoli, Italy, 80131
        • AOU Luigi Vanvitelli
      • Rozzano, Italy, 20089
        • PellePharm Investigative Site
      • Vicenza, Italy, 36100
        • PellePharm Investigative Site
  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • PellePharm Investigative Site
  • Spain
      • Barcelona, Spain, 08036
        • PellePharm Investigative Site
      • Madrid, Spain, 28023
        • PellePharm Investigative Site
      • Madrid, Spain, 28034
        • PellePharm Investigative Site
      • Sevilla, Spain, 41009
        • PellePharm Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom
        • PellePharm Investigative Site
      • London, United Kingdom
        • PellePharm Investigative Site
      • Manchester, United Kingdom
        • PellePharm Investigative Site
      • Oxford, United Kingdom
        • PellePharm Investigative Site
  • United States
    • California
      • Fremont, California, United States, 94538
        • PellePharm Investigative Site
      • Newport Beach, California, United States, 92660
        • PellePharm Investigative Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University
    • Florida
      • Miami, Florida, United States, 33125
        • PellePharm Investigative Site
      • Ormond Beach, Florida, United States, 32174
        • PellePharm Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • PellePharm Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Laser & Skin Surgery Center of Indiana
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • PellePharm Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Utah
      • Murray, Utah, United States, 84107
        • University of Utah, Midvalley Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject must have completed PellePharm Study Pelle-926-201 or Pelle-926-301.
  2. Study Pelle-926-301 subjects must have completed the End of Treatment Visit in Study 301, prior to the Screening Visit in this study. They must also complete all Study 301 related procedures prior to the Baseline Visit of this study.
  3. 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 except as prescribed by the Investigator. Moisturizers and emollients are allowed. Subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (SPF) of at least 30 daily on all exposed skin sites.
  4. Female subjects must have a negative pregnancy test. For Study 301 subjects a negative serum pregnancy test result from Study 301 is acceptable if the test was done within 7 days of the Screening Visit of this study.
  5. If the subject is a woman of child bearing potential (WOCBP), she must be willing to use birth control methods which may be considered highly effective. Hormonal contraception must be supplemented with a barrier method (preferably condom). Birth control must start prior to Baseline, continue through the duration of the study, and for 30 days after last application of investigational product (IP).
  6. If the subject is a male with a female sex partner who is a WOCBP, the subject must be willing to use condoms, even after a vasectomy, starting prior to Baseline, through the duration of the study, and for at least 3 months after the last application of IP.
  7. The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator.
  8. The subject is willing to forego treatment of facial BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a BCC potentially might compromise the health of the subject. In such instances, the only other allowed form of treatment is surgical.

Exclusion Criteria:

  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 has current, recent (within five half lives of the experimental drug or if half life not known, within the past 6 months prior to the Screening Visit), or planned (while enrolled in this study) participation in an experimental drug study (excluding Study 301).
  3. The subject is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.
  4. The subject is pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patidegib Topical Gel, 2%
Drug: Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in number of facial BCCs removed by surgery
Time Frame: 12 months
12 months
Change in number of new lesions suspicious for BCC
Time Frame: 12 months
12 months
Change in Advanced Basal Cell Carcinoma Index (aBCCdex) lesion score
Time Frame: 12 months
12 months
Change in Dermatology Life Quality Index (DLQI)
Time Frame: 12 months
12 months
Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sol-Gel Technologies, Ltd.

Investigators

  • Study Director: Study Director VP, Clinical Operations, PellePharm, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2020

Primary Completion (Actual)

July 14, 2021

Study Completion (Actual)

July 14, 2021

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pelle-926-301E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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