Recurrent Basal Cell CarcinomaPhase 2NCT04155190

A 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

A Phase 2 study testing Patidegib Topical Gel, 2% in people with Recurrent Basal Cell Carcinoma, run by Sol-Gel Technologies, Ltd. at 14 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Basal Cell Carcinoma
What is being tested?: Patidegib Topical Gel, 2%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 14 sitesUnited States
Study dates: 20 Dec 2019to 23 Apr 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Axiom Research, LLC
Apple Valley, California, 92307
Axiom Research, LLC
Colton, California, 92324
Palm Beach Dermatology Research
Delray Beach, Florida, 33484
Duke University Medical Center
Durham, North Carolina, 27710
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Skin Laser and Surgery Specialists of NY&NJ
Hackensack, New Jersey, 07601
PellePharm Investigative Site
Henderson, Nevada, 89052
Dermatology Research Associates
Los Angeles, California, 90045
University of Utah
Murray, Utah, 84107
The Dermatology Center of Newport
Newport Beach, California, 92660
Leavitt Medical Associates of Florida
Ormond Beach, Florida, 32174
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
PellePharm Investigative Site
Saint Augustine, Florida, 32080
Grekin Skin Institute
Warren, Michigan, 48088

Other trials in United States

About this study

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

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.

Conditions: Recurrent Basal Cell Carcinoma
Being tested: Patidegib Topical Gel, 2%, Patidegib Topical Gel, Vehicle
Keywords: 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
Medical subject headings: Carcinoma, Basal Cell, Rombo syndrome, Xeroderma Pigmentosum, Syndrome, Basal Cell Nevus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patidegib Topical Gel, 2%Drug
Also called IP
Patidegib Topical Gel, 2%
Patidegib Topical Gel, VehicleDrug
Also called IP, Vehicle
Patidegib Topical Gel, Vehicle

Study groups in NCT04155190
Study group	Role	What they receive
Patidegib Topical Gel, 2%	Experimental	Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months Receives: Drug: Patidegib Topical Gel, 2%
Patidegib Topical Gel, Vehicle	Active comparator	Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months Receives: Drug: Patidegib Topical Gel, Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)
Measured: Up to 9 months

Secondary outcomes (1)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that started on or after the first dose of study drug. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Measured: Up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 201923 Apr 2021

First posted7 Nov 2019
Study start20 Dec 2019
Primary completion23 Apr 2021
Study completion23 Apr 2021

Why it stopped: Terminated early due to low blinded event rate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recurrent Basal Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04155190
Sponsor's protocol ID: Pelle-926-203
Status last verified: Jun 2026
First submitted: 1 Nov 2019
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Recurrent Basal Cell Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04155190
Acronym / sponsor ID: Pelle-926-203
Conditions: Recurrent Basal Cell Carcinoma
Keywords: High Frequency Basal Cell Carcinoma, non-gorlin, HF-BCC, Bazex-Dupré-Christol Syndrome, Rombo Syndrome, Oley Syndrome, Xeroderma Pigmentosum (XP) Syndrome, BCC
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated early due to low blinded event rate
Enrolment: 50 participants (actual)
Lead sponsor: Sol-Gel Technologies, Ltd.Industry (pharma, biotech, devices)
Study start: 20 Dec 2019 (actual)
Primary completion: 23 Apr 2021 (actual)
Study completion: 23 Apr 2021 (actual)
First posted: 7 Nov 2019 (actual)
Results: Posted 21 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
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.

Arm	Type	Receives
Patidegib Topical Gel, 2%	Experimental	Drug: Patidegib Topical Gel, 2%Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
Patidegib Topical Gel, Vehicle	Active comparator	Drug: Patidegib Topical Gel, VehicleParticipants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patidegib Topical Gel, 2%Also: IPPatidegib Topical Gel, 2%	Drug	Patidegib Topical Gel, 2%
Patidegib Topical Gel, VehicleAlso: IP, VehiclePatidegib Topical Gel, Vehicle	Drug	Patidegib Topical Gel, Vehicle

Primary outcome

Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)
Time frame: Up to 9 months

1 secondary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 9 months

Results and safety

Results posted to the registry on 21 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study	50	20

Primary outcome: Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)

Time frame: Up to 9 months

Population analysed: As detailed in the current Sponsor's Note to File for the Statistical Analysis Plan, Sol-Gel was not provided data to indicate if any of the basal cell carcinomas (BCC) events met the protocol-specified criteria to determine the event as a nSEB.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 9 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall Study	2 of 47 (4.3%)	0 of 47 (0%)	0 of 47

Limitations and caveats (from the sponsor): Study terminated early by previous responsible party (PellePharm Inc.) due to low blinded event rate. Data presented reflect data collected prior to study termination by PellePharm, and are reported by current responsible party, Sol-Gel. Participant-level data collected and reported only in aggregate for overall study, rather than by treatment arm for participant flow, outcome measures, mortality, and AEs. Current Sponsor prepared a Note to File for SAP to document how data were collected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Recurrent Basal Cell Carcinoma

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

VP, Clinical Operations study director

PellePharm, Inc.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patidegib Topical Gel, 2% in people with Recurrent Basal Cell Carcinoma, run by Sol-Gel Technologies, Ltd. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs) (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155190.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.