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Spots Global Cancer Trial Database for 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 (Gorlin Syndrome)

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Trial Identification

Brief Title: 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 (Gorlin Syndrome)

Official 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

Study ID: NCT03703310

Study Description

Brief Summary: This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.

Detailed Description: An open-label, extension safety and tolerability study is planned for at least 12 months duration following the end of this study. All participants who complete the Month 12 Exit Visit having demonstrated adequate compliance with application of the Investigational Product (IP) without major Protocol Deviations (PDs) during the study will be eligible for participation in the extension study. All participants will be contacted by phone approximately 30 days following the Exit or Discontinuation Visit to determine if the participant has experienced any new adverse events (AEs)/serious AEs (SAEs) since discontinuation/completion of study treatment.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinical Cancer Center, Phoenix, Arizona, United States

Dermatology Center of Newport, Newport Beach, California, United States

Stanford University, Department of Dermatology, Redwood City, California, United States

University of California, San Francisco, San Francisco, California, United States

Yale School of Medicine, New Haven, Connecticut, United States

University of Miami Miller School of Medicine, Miami, Florida, United States

Leavitt Medical Associates of Florida, Ormond Beach, Florida, United States

The University of Chicago, Chicago, Illinois, United States

Laser & Skin Surgery Center of Indiana, Carmel, Indiana, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

University of Michigan, Dept of Dermatology, Ann Arbor, Michigan, United States

University of Minnesota, Department of Dermatology, Minneapolis, Minnesota, United States

Saint Louis University Dermatology, Saint Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Columbia University Medical Center, New York, New York, United States

Duke University, Durham, North Carolina, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Oregon Health and Science University, Portland, Oregon, United States

Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center, Houston, Texas, United States

University of Utah Midvalley Dermatology, Murray, Utah, United States

PellePharm Investigative Site, Brussels, , Belgium

PellePharm Investigative Site, Leuven, , Belgium

Clinical Trials Unit - The Skin Care Centre, Vancouver, British Columbia, Canada

Pellepharm Investigative Site, Toronto, , Canada

PellePharm Investigative Site, Copenhagen, , Denmark

Hopital Saint-Andre - CHU Bordeaux, Bordeaux Cedex, , France

CHRU de Lille - Hopital Claude HURIEZ, Lille Cedex, , France

CHU La Timone, Marseille, , France

PellePharm Investigative Site, Nantes, , France

Hopital Saint-Louis, Paris, , France

PellePharm Investigative Site, Pierre-Bénite, , France

Charite - Universitatsmedizin Berlin, Berlin, , Germany

Klinik und Poliklinik fur Dermatologie und Allergologie, Munich, , Germany

Universitatsklinikum Münster, Münster, , Germany

Universitats Hautklinik, Tübingen, , Germany

Ospedale Vanvitelli-University della Campania-Dermatologia Edificio 9, Napoli, , Italy

Catholic University of the Sacred Heart, Roma, , Italy

Humanitas University Milan, Rozzano, , Italy

Ospedale San Bortolo, Vicenza, , Italy

Maastricht University Medical Center - Dept of Dermatology, Maastricht, , Netherlands

Hospital Clinic I Provincial, Barcelona, , Spain

Hospital Universitario Ramon y Cajal, Madrid, , Spain

Hospital Universitiario Virgen de la Macarena, Sevilla, , Spain

NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom

Royal London Hospital, London, , United Kingdom

Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom

Salford Royal Hospital, Salford, , United Kingdom

Contact Details

Name: VP, Clinical Operations

Affiliation: PellePharm, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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