Trial Outcomes & Findings for 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 (NCT NCT04155190)
NCT ID: NCT04155190
Last Updated: 2026-07-21
Results Overview
TERMINATED
PHASE2
50 participants
Up to 9 months
2026-07-21
Participant Flow
The study was terminated early by the previous responsible party (PellePharm Inc.) on 15-Jun-2021 due to low blinded event rate. Data presented in this results posting reflect the data collected prior to study termination by the previous responsible party, PellePharm Inc., and are reported by the current responsible party, Sol-Gel Technologies Ltd.
The study was originally planned as a 2-arm study. However, participant-level data were collected and reported only in aggregate for the overall study, rather than by treatment arm for participant flow, study outcome measures, all-cause mortality, and adverse event data. The current Sponsor (Sol-Gel) prepared a Note to File for the Statistical Analysis Plan (SAP) to document how the data were collected.
Participant milestones
| Measure |
Overall Study
Participants received patidegib topical gel, 2% or vehicle, applied twice daily to the face for up to 9 months.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
Intent to Treat Set
|
47
|
|
Overall Study
Received at Least 1 Dose of Patidegib or Vehicle
|
47
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Overall Study
Participants received patidegib topical gel, 2% or vehicle, applied twice daily to the face for up to 9 months.
|
|---|---|
|
Overall Study
Sponsor decision
|
24
|
|
Overall Study
Other than specified
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Randomized, not treated
|
3
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Patidegib Topical Gel, 2%
n=23 Participants
Participants received patidegib topical Gel, 2% applied twice daily to the face for up to 9 months.
|
Vehicle
n=24 Participants
Participants received patidegib topical Gel, vehicle applied twice daily to the face for up to 9 months.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
32 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
47 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: Safety set included all participants who received at least 1 dose of study drug. Data presented in this results posting reflect data collected prior to study termination by previous responsible party, PellePharm, and are reported by current responsible party, Sol-Gel. As documented in the Note to File for the SAP, participant-level data were collected and reported only in aggregate for the overall study, rather than by treatment arm for study outcome measures.
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'.
Outcome measures
| Measure |
Overall Study
n=47 Participants
Participants received patidegib topical gel, 2% or vehicle, applied twice daily to the face for up to 9 months.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
18 Participants
|
Adverse Events
Overall Study
Serious adverse events
| Measure |
Overall Study
n=47 participants at risk
Participants received patidegib topical gel, 2% or vehicle, applied twice daily to the face for up to 9 months.
|
|---|---|
|
Infections and infestations
Respiratory syncytial virus infection
|
2.1%
1/47 • Number of events 1 • Up to 9 months
Safety set included all participants who received at least 1 dose of study drug. Data presented in this results posting reflect data collected prior to study termination by previous responsible party, PellePharm, and are reported by current responsible party, Sol-Gel. As documented in the Note to File for the SAP, participant-level data were collected and reported only in aggregate for the overall study, rather than by treatment arm for All-cause mortality and AEs.
|
|
Cardiac disorders
Myocardial Infarction
|
2.1%
1/47 • Number of events 1 • Up to 9 months
Safety set included all participants who received at least 1 dose of study drug. Data presented in this results posting reflect data collected prior to study termination by previous responsible party, PellePharm, and are reported by current responsible party, Sol-Gel. As documented in the Note to File for the SAP, participant-level data were collected and reported only in aggregate for the overall study, rather than by treatment arm for All-cause mortality and AEs.
|
Other adverse events
Adverse event data not reported
Additional Information
VP Clinical & Regulatory Affairs
Sol-Gel Technologies, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place