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 :
Recruiting
First Posted : November 7, 2019
Last Update Posted : September 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Basal Cell Carcinoma | Drug: Patidegib Topical Gel, 2% Drug: Patidegib Topical Gel, Vehicle | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Patidegib Topical Gel, 2%
Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
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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 |
- Number of new surgically eligible BCCs (nSEBs) [ Time Frame: Baseline through Month 9 ]
- Number of treatment emergent adverse events assessed with means and standard errors or proportions [ Time Frame: Baseline through Month 9 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
- 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:
- The subject has been previously diagnosed with Gorlin syndrome
- On medical history, family history or clinical examination there is a suspicion that the patient has Gorlin syndrome.
- Patients with a family history of medulloblastoma
- The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.
- The subject has uncontrolled systemic disease.
- 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.

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
Contact: Sr. Clinical Operations Manager | 844-332-5161 | clinical@pellepharm.com |
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 |
Study Director: | VP, Clinical Operations | PellePharm, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Basal Cell Veratrum Alkaloids Antihypertensive Agents |