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Trial record 1 of 64 for:    Basal Cell Carcinoma Recurrent
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155190
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
PellePharm, Inc.

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 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
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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.
Contacts and Locations
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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


Contacts
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Contact: Sr. Clinical Operations Manager 844-332-5161 clinical@pellepharm.com

Locations
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United States, California
Axiom Research, LLC Recruiting
Apple Valley, California, United States, 92307
Contact: Pamela West    760-946-9027    pamelawest@axiomresearch.com   
Principal Investigator: Dennis Anderson, MD         
Axiom Research, LLC Recruiting
Colton, California, United States, 92324
Contact: Pamela West    909-824-2325    pamelawest@axiomresearch.com   
Principal Investigator: Kenneth Macknet, MD         
Center for Dermatology Clinical Research, Inc. Recruiting
Fremont, California, United States, 94538
Contact: Natalia Cobian    510-797-0160    nataliac@ctr4derm.com   
Principal Investigator: Sunil Dhawan, MD         
Dermatology Research Associates Recruiting
Los Angeles, California, United States, 90045
Contact: Laura Mannas    310-337-7171    lmannas@drsofen.com   
Principal Investigator: Howard Sofen, MD         
The Dermatology Center of Newport Recruiting
Newport Beach, California, United States, 92660
Contact: Francisco Aguirre    949-525-0700    f.aguirre@dermatologyofnewport.com   
Principal Investigator: Michelle Aszterbaum, MD         
United States, Florida
Palm Beach Dermatology Research Recruiting
Delray Beach, Florida, United States, 33484
Contact: Scott Grimstead    561-499-0660    scottg@stkinnovation.com   
Principal Investigator: Adam S Plotkin, MD         
Leavitt Medical Associates of Florida Recruiting
Ormond Beach, Florida, United States, 32174
Contact: Sandra Warrington    386-523-0768    swarrington@ameridermresearch.com   
Principal Investigator: James Solomon, MD, PhD         
PellePharm Investigative Site Recruiting
Saint Augustine, Florida, United States, 32080
Contact       clinical@pellepharm.com   
United States, Indiana
The Indiana Clinical Trials Center Recruiting
Plainfield, Indiana, United States, 46168
Contact: Amy Saenz, CCRC    317-837-6082    asaenz@indianatrials.com   
Principal Investigator: Scott Guenthner, MD         
United States, Michigan
Grekin Skin Institute Recruiting
Warren, Michigan, United States, 48088
Contact: Claudia Attala    586-759-5525    claudia.attala@adcsclinics.com   
Principal Investigator: Steven Grekin, MD         
United States, Nevada
PellePharm Investigative Site Recruiting
Henderson, Nevada, United States, 89052
Contact       clinical@pellepharm.com   
United States, New Jersey
Skin Laser and Surgery Specialists of NY&NJ Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diana Aranzazu    201-441-9890 ext 2071    dianaa@skinandlasers.com   
Principal Investigator: David Goldberg, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kim Scoggins    919-684-1830    kim.scoggins@duke.edu   
Principal Investigator: Meenal Kheterpal, MD         
United States, Utah
University of Utah Recruiting
Murray, Utah, United States, 84107
Contact: Sean Wentland    801-213-3427    sean.wentland@hsc.utah.edu   
Principal Investigator: Keith Duffy, MD         
Sponsors and Collaborators
PellePharm, Inc.
Investigators
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Study Director: VP, Clinical Operations PellePharm, Inc.
More Information
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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: September 28, 2020
Last Verified: September 2020
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
Basal Cell Nevus Syndrome
Basal Cell Carcinoma
Surgically Eligible Basal Cell Carcinoma
non-gorlin
HF-BCC
Bazex-Dupré-Christol Syndrome
Rombo Syndrome
 Oley Syndrome
Xeroderma Pigmentosum (XP) Syndrome
BCC
SEB
Hedgehog inhibitor
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