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

Recruitment Status
TERMINATED - HAS RESULTS
(See Contacts and Locations)Verified June 2024 by Sol-Gel Technologies, Ltd.
Sponsor
Sol-Gel Technologies, Ltd.
Information Provided by (Responsible Party)
Sol-Gel Technologies, Ltd.
Clinicaltrials.gov Identifier
NCT04308395
Other Study ID Numbers:
Pelle-926-301E
First Submitted
March 10, 2020
First Posted
March 15, 2020
Results First Posted
July 20, 2024
Last Update Posted
September 23, 2024
Last Verified
June 2024

ClinicalTrials.gov processed this data on August 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Basal Cell Nevus Syndrome
Drug: Patidegib Topical Gel, 2%

Study Design

Study TypeInterventional
Actual Enrollment108 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
Study Start DateJune 2, 2020
Actual Primary Completion DateJuly 13, 2021
Actual Study Completion DateJuly 13, 2021

Groups and Cohorts

Group/CohortIntervention/Treatment
Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%
Drug: Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%

Outcome Measures

Primary Outcome Measures
  1. Incidence of Treatment-emergent Adverse Events (TEAEs)
    IMP=Investigational medicinal product; Unique adverse event = adverse event of a certain preferred term, counted only once within each subject. Related adverse event = adverse event with relationship as Definitely, Probably or Possibly.
Secondary Outcome Measures
  1. Change in Number of Facial BCCs Removed by Surgery
  2. Change in Number of New Lesions Suspicious for BCC
  3. Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score
  4. Change in Dermatology Life Quality Index (DLQI)
  5. Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsSol-Gel Technologies, Ltd.
Locations
PellePharm Investigative Site | Fremont California, United States, 94538PellePharm Investigative Site | Newport Beach California, United States, 92660Yale University | New Haven Connecticut, United States, 06519Pellepharm Investigative Site | Miami Florida, United States, 33125PellePharm Investigative Site | Ormond Beach Florida, United States, 32174PellePharm Investigative Site | Chicago Illinois, United States, 60637Laser & Skin Surgery Center of Indiana | Indianapolis Indiana, United States, 46260Pellepharm Investigative Site | Ann Arbor Michigan, United States, 48109University of Minnesota | Minneapolis Minnesota, United States, 55455Saint Louis University | St Louis Missouri, United States, 63104Columbia University Irving Medical Center | New York New York, United States, 10032Duke University Medical Center | Durham North Carolina, United States, 27710Cleveland Clinic | Cleveland Ohio, United States, 44195Oregon Health and Science University | Portland Oregon, United States, 97239Penn State Health Milton S. Hershey Medical Center | Hershey Pennsylvania, United States, 17033MD Anderson Cancer Center | Houston Texas, United States, 77030University of Utah, Midvalley Dermatology | Murray Utah, United States, 84107PellePhram Investigative Site | Leuven , Belgium, 3000PellePharm Investigative Site | Copenhagen , Denmark, DK-2400PellePharm Investigative Site | Lille , France, PellePharm Investigative Site | Nantes , France, 44093Hopital Saint Louis | Paris , France, 75010PellePharm Investigative Site | Berlin , Germany, 10117PellePharm Investigative Site | Munich , Germany, 80337PellePharm Investigative Site | Münster , Germany, 48149AOU Luigi Vanvitelli | Naples , Italy, 80131PellePharm Investigative Site | Rozzano , Italy, 20089PellePharm Investigative Site | Vicenza , Italy, 36100PellePharm Investigative Site | Maastricht , Netherlands, 6229 HXPellePharm Investigative Site | Barcelona , Spain, 08036PellePharm Investigative Site | Madrid , Spain, 28023PellePharm Investigative Site | Madrid , Spain, 28034PellePharm Investigative Site | Seville , Spain, 41009PellePharm Investigative Site | Glasgow , United Kingdom, PellePharm Investigative Site | London , United Kingdom, PellePharm Investigative Site | Manchester , United Kingdom, PellePharm Investigative Site | Oxford , United Kingdom,
Investigators
Study Director: Study Director VP, Clinical Operations, PellePharm, Inc.
Study Documents (Full Text)
Documents provided by Sol-Gel Technologies, Ltd.: Study Protocol  January 29, 2020Documents provided by Sol-Gel Technologies, Ltd.: Statistical Analysis Plan  April 15, 2020