Trial · NCT04308395
Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
NCT04308395, Phase 3, Terminated, Sol-Gel Technologies, Ltd.; results first posted 2024-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome). Trials, record NCT04308395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04308395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
- NCT number
- NCT04308395
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 108 participants, actual
- Lead sponsor
- Sol-Gel Technologies, Ltd.
- Conditions
- Basal Cell Nevus Syndrome
- Interventions
- Patidegib Topical Gel, 2%
- First posted
- 2020-03-16
- Last updated
- 2024-09-24
- Results first posted
- 2024-09-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-emergent Adverse Events (TEAEs) | 12 months | IMP=Investigational medicinal product; Unique adverse event = adverse event of a certain preferred term, counted only once within each subject. Related adverse event = adverse event with relationship as Definitely, Probably or Possibly. |
| Secondary | Change in Number of Facial BCCs Removed by Surgery | 12 months | |
| Secondary | Change in Number of New Lesions Suspicious for BCC | 12 months | |
| Secondary | Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score | 12 months | |
| Secondary | Change in Dermatology Life Quality Index (DLQI) | 12 months | |
| Secondary | Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L) | 12 months |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment-emergent Adverse Events (TEAEs) | 12 months | Number of subjects | NUMBER | |
| SECONDARY | Change in Number of Facial BCCs Removed by Surgery | 12 months | Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected | ||
| SECONDARY | Change in Number of New Lesions Suspicious for BCC | 12 months | Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected | ||
| SECONDARY | Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score | 12 months | Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected | ||
| SECONDARY | Change in Dermatology Life Quality Index (DLQI) | 12 months | Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected | ||
| SECONDARY | Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L) | 12 months | Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected | ||
| PRIMARY | Incidence of Treatment-emergent Adverse Events (TEAEs) | 12 months | Number of adverse events | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least one adverse event | 46 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least one adverse event related to IMP | 6 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least leading to treatment discontinuation | 0 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least one AE related to IMP leading to treatment discontinuation | 0 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least one paralesional adverse event | 3 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least one serious adverse event | 3 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least one serious adverse event related to IMP | 0 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects withat least one adverse event leading to death | 0 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Number of subjects with at least one adverse event related to IMP leading to death | 0 | Number of subjects | |
| Incidence of Treatment-emergent Adverse Events (TEAEs) | Patidegib Topical Gel, 2% | Total number of adverse events | 82 | Number of adverse events |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patidegib Topical Gel, 2% | 108 | |
| Overall Study | COMPLETED | Patidegib Topical Gel, 2% | 3 | |
| Overall Study | NOT COMPLETED | Patidegib Topical Gel, 2% | 105 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | No adverse event occured in 5% or more of the patients | General disorders | Patidegib Topical Gel, 2% | 46 | 105 | 82 |
| serious | Atrial fibrillation | Cardiac disorders | Patidegib Topical Gel, 2% | 1 | 105 | 1 |
| serious | Craniocerebral injury | Injury, poisoning and procedural complications | Patidegib Topical Gel, 2% | 1 | 105 | 1 |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Patidegib Topical Gel, 2% | 1 | 105 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patidegib Topical Gel, 2% | 0 | 105 |
| Total, other adverse events | Patidegib Topical Gel, 2% | 46 | 105 |
| Total, serious adverse events | Patidegib Topical Gel, 2% | 3 | 105 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04308395
GET https://conductscience.org/api/trials/v1/NCT04308395/registered