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An Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas in Patients With Non-Gorlin High Frequency BCC

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ClinicalTrials.gov Identifier: NCT04155190
Recruitment Status : Terminated (Terminated early due to low blinded event rate)
First Posted : November 7, 2019
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
PellePharm, Inc.

Brief Summary:
This is a 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 non-Gorlin HF-BCC (high-frequency basal cell carcinoma). Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender. The primary endpoint is the number of nSEB (surgically eligible basal cell carcinoma) that develop on the face over the 9 month period. The primary end point will be assessed by imaging and tracking of BCCs consistently throughout the study in order to identify nSEBs.

Condition or disease Intervention/treatment Phase
Recurrent Basal Cell Carcinoma Drug: Patidegib Topical Gel, 2% Drug: Patidegib Topical Gel, Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized (1:1) to receive either Patidegib Topical Gel, 2%, or Vehicle for 9 months. Randomization will be stratified by gender.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: As a double-blinded study, the Investigators, the site staff, PellePharm, and the Clinical Monitor(s) will be blinded to the treatment assigned to individual subjects. Delegated staff members at the study site will dispense the investigational product (IP) and will collect and weigh all used and unused IP tubes.
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients With Non-Gorlin High Frequency BCC
Actual Study Start Date : December 20, 2019
Actual Primary Completion Date : April 23, 2021
Actual Study Completion Date : April 23, 2021


Arm Intervention/treatment
Experimental: Patidegib Topical Gel, 2%
Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
Drug: Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%
Other Name: IP

Active Comparator: Patidegib Topical Gel, Vehicle
Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months
Drug: Patidegib Topical Gel, Vehicle
Patidegib Topical Gel, Vehicle
Other Name: IP, Vehicle




Primary Outcome Measures :
  1. Number of new surgically eligible BCCs (nSEBs) [ Time Frame: Baseline through Month 9 ]

Secondary Outcome Measures :
  1. Number of treatment emergent adverse events assessed with means and standard errors or proportions [ Time Frame: Baseline through Month 9 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter <5 mm present on the face prior to Screening and Randomization (Baseline/Day 1).
  2. 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.

Exclusion Criteria:

  1. The subject has been previously diagnosed with Gorlin syndrome
  2. On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.
  3. Patients with a family history of medulloblastoma
  4. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
  5. The subject has uncontrolled systemic disease.
  6. The subject has been treated for invasive cancer within the past 5 years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or chronic lymphocytic leukemia (CLL) Stage 0.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155190


Locations
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United States, California
Axiom Research, LLC
Apple Valley, California, United States, 92307
Axiom Research, LLC
Colton, California, United States, 92324
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
Dermatology Research Associates
Los Angeles, California, United States, 90045
The Dermatology Center of Newport
Newport Beach, California, United States, 92660
United States, Florida
Palm Beach Dermatology Research
Delray Beach, Florida, United States, 33484
Leavitt Medical Associates of Florida
Ormond Beach, Florida, United States, 32174
PellePharm Investigative Site
Saint Augustine, Florida, United States, 32080
United States, Indiana
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Nevada
PellePharm Investigative Site
Henderson, Nevada, United States, 89052
United States, New Jersey
Skin Laser and Surgery Specialists of NY&NJ
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Utah
University of Utah
Murray, Utah, United States, 84107
Sponsors and Collaborators
PellePharm, Inc.
Investigators
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Study Director: VP, Clinical Operations PellePharm, Inc.
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Responsible Party: PellePharm, Inc.
ClinicalTrials.gov Identifier: NCT04155190    
Other Study ID Numbers: Pelle-926-203
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PellePharm, Inc.:
High Frequency Basal Cell Carcinoma
non-gorlin
HF-BCC
Bazex-Dupré-Christol Syndrome
Rombo Syndrome
Oley Syndrome
Xeroderma Pigmentosum (XP) Syndrome
BCC
SEB
Hedgehog inhibitor
Basal Cell Nevus Syndrome
Basal Cell Carcinoma
Surgically Eligible Basal Cell Carcinoma
patidegib
HFBCC
HHI
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Veratrum Alkaloids
Antihypertensive Agents