A Phase 2 interventional study of Patidegib Topical Gel, 2% and Patidegib Topical Gel, Vehicle in Recurrent Basal Cell Carcinoma, sponsored by Sol-Gel Technologies, Ltd.. Terminated at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Sol-Gel Technologies, Ltd. · Phase 2, Interventional, and Treatment
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.
389 studies on the registry are indexed under Carcinoma, Basal Cell; 69 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 272 interventional studies indexed under Carcinoma, Basal Cell.
Browse Carcinoma, Basal Cell studies →Sol-Gel Technologies, Ltd. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
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Exclusion Criteria:
Participants will be randomized (1:1) to receive Patidegib Topical Gel, 2% for 9 months
Drug: Patidegib Topical Gel, 2%
Participants will be randomized (1:1) to receive Patidegib Topical Gel, Vehicle for 9 months
Drug: Patidegib Topical Gel, Vehicle
Patidegib Topical Gel, 2%
Also known as: IP
Patidegib Topical Gel, Vehicle
Also known as: IP, Vehicle
Number of Participants With New Surgically Eligible Basal Cell Carcinomas (nSEBs)
Time frame: Up to 9 months
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'.
Time frame: Up to 9 months
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.
| Milestone | Overall Study |
|---|---|
| Started | 50 |
| Intent to treat set | 47 |
| Received at least 1 dose of patidegib or vehicle | 47 |
| Completed | 20 |
| Not completed | 30 |
| Withdrew: Sponsor decision | 24 |
| Withdrew: Other than specified | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Randomized, not treated | 3 |
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'.
| Participants | Overall Study |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 18 |
No measurements were reported for this outcome.
Collected over Up to 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study | 0/47 (0%) | 2/47 (4.3%) | 0/47 (0%) |
| Event | Overall Study |
|---|---|
| Respiratory syncytial virus infectionInfections and infestations | 1/47 |
| Myocardial InfarctionCardiac disorders | 1/47 |
Intent to treat set included all participants who received at least 1 dose of study drug.
| Age, Categorical(Participants) | Patidegib Topical Gel, 2% | Vehicle | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 4 | 11 |
| >=65 years | 16 | 20 | 36 |
| Sex: Female, Male(Participants) | Patidegib Topical Gel, 2% | Vehicle | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 16 | 16 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Patidegib Topical Gel, 2% | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 23 | 24 | 47 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patidegib Topical Gel, 2% | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 23 | 24 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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Studies of the drug tested here: Patidegib Topical Gel
Sol-Gel Technologies, Ltd.