Trial · NCT03703310
Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)
NCT03703310, Phase 3, Completed, Sol-Gel Technologies, Ltd.; results first posted 2024-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome). Trials, record NCT03703310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03703310
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects With Basal Cell Nevus Syndrome (Gorlin Syndrome)
- NCT number
- NCT03703310
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 174 participants, actual
- Lead sponsor
- Sol-Gel Technologies, Ltd.
- Conditions
- Basal Cell Nevus Syndrome
- Interventions
- Patidegib Topical Gel, 2%, Patidegib Topical Gel, Vehicle
- First posted
- 2018-10-11
- Last updated
- 2024-07-03
- Results first posted
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of New BCCs Per Participant | Month 12 | |
| Secondary | Number of New Surgically Eligible BCCs (nSEBs) Per Participant | Month 12 | |
| Secondary | Percentage of Participants Developing >=2 Facial New BCCs | Month 12 | |
| Secondary | Percentage of Participants Developing >=1 Facial New BCCs | Month 12 | |
| Secondary | Number of New BCCs Per Participant | Month 9 | |
| Secondary | Number of New BCCs Per Participant | Month 6 | |
| Secondary | Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Symptom Score Scale Score | Month 12 | The Advanced Basal Cell Carcinoma Index (aBCCdex) measures the impact of basal cell carcinoma on patients' quality of life. The index consists of several subscales, each subscale with its own range of scores for each question Lesion Symptoms Scale: Scores range from 1 to 7 and it includes 6 questions. Therefore the total score range is from 6 (minimum) to 42 (maximum), where a higher score correlates with a poorer quality of life. |
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 | Number of New BCCs Per Participant | Month 12 | The number of BCCs per subject by Month 12 summarized subjects with BCC assessments within the Month 12 analysis window. | New basal cell carcinomas | MEAN |
| SECONDARY | Number of New Surgically Eligible BCCs (nSEBs) Per Participant | Month 12 | The number of nSEBs per subject by Month 12 summarizes subjects with BCC assessments within the Month 12 analysis window. | New basal cell carcinomas | MEAN |
| SECONDARY | Percentage of Participants Developing >=2 Facial New BCCs | Month 12 | subjects with no postbaseline data were excluded from the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Developing >=1 Facial New BCCs | Month 12 | subjects with no postbaseline data were excluded from the analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of New BCCs Per Participant | Month 9 | subjects with no postbaseline data were excluded from the analysis | New basal cell carcinomas | MEAN |
| SECONDARY | Number of New BCCs Per Participant | Month 6 | subjects with no postbaseline data were excluded from the analysis | New basal cell carcinomas | MEAN |
| SECONDARY | Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Symptom Score Scale Score | Month 12 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of New BCCs Per Participant | Patidegib Topical Gel, 2%, | 2.84 | Standard Deviation 3.39 | New basal cell carcinomas | |
| Number of New BCCs Per Participant | Patidegib Topical Gel, Vehicle | 4.03 | Standard Deviation 4.76 | New basal cell carcinomas | |
| Number of New Surgically Eligible BCCs (nSEBs) Per Participant | Patidegib Topical Gel, 2%, | 0.71 | Standard Deviation 1.28 | New basal cell carcinomas | |
| Number of New Surgically Eligible BCCs (nSEBs) Per Participant | Patidegib Topical Gel, Vehicle | 0.91 | Standard Deviation 1.61 | New basal cell carcinomas | |
| Percentage of Participants Developing >=2 Facial New BCCs | Patidegib Topical Gel, 2%, | 45 | Participants | ||
| Percentage of Participants Developing >=2 Facial New BCCs | Patidegib Topical Gel, Vehicle | 55 | Participants | ||
| Percentage of Participants Developing >=1 Facial New BCCs | Patidegib Topical Gel, 2%, | 56 | Participants | ||
| Percentage of Participants Developing >=1 Facial New BCCs | Patidegib Topical Gel, Vehicle | 65 | Participants | ||
| Number of New BCCs Per Participant | Patidegib Topical Gel, 2%, | 2.46 | Standard Deviation 3.42 | New basal cell carcinomas | |
| Number of New BCCs Per Participant | Patidegib Topical Gel, Vehicle | 3.15 | Standard Deviation 3.94 | New basal cell carcinomas |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patidegib Topical Gel, 2%, | 87 | |
| Overall Study | STARTED | Patidegib Topical Gel, Vehicle | 87 | |
| Overall Study | COMPLETED | Patidegib Topical Gel, 2%, | 67 | |
| Overall Study | COMPLETED | Patidegib Topical Gel, Vehicle | 70 | |
| Overall Study | NOT COMPLETED | Patidegib Topical Gel, 2%, | 20 | |
| Overall Study | NOT COMPLETED | Patidegib Topical Gel, Vehicle | 17 |
Source ClinicalTrials.gov
Adverse events56
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 | Upper respiratory tract infection | Infections and infestations | Patidegib Topical Gel, 2%, | 5 | 87 | |
| other | Upper respiratory tract infection | Infections and infestations | Patidegib Topical Gel, Vehicle | 9 | 87 | |
| other | Urinary tract infection | Infections and infestations | Patidegib Topical Gel, 2%, | 5 | 87 | |
| other | Urinary tract infection | Infections and infestations | Patidegib Topical Gel, Vehicle | 6 | 87 | |
| other | Nasopharyngitis | Infections and infestations | Patidegib Topical Gel, 2%, | 2 | 87 | |
| other | Nasopharyngitis | Infections and infestations | Patidegib Topical Gel, Vehicle | 10 | 87 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Patidegib Topical Gel, 2%, | 5 | 87 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Patidegib Topical Gel, Vehicle | 11 | 87 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Patidegib Topical Gel, 2%, | 4 | 87 | |
| other | Dry skin | Skin and subcutaneous tissue disorders | Patidegib Topical Gel, Vehicle | 9 | 87 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patidegib Topical Gel, 2%, | 0 | 87 |
| Total, all-cause mortality | Patidegib Topical Gel, Vehicle | 0 | 87 |
| Total, other adverse events | Patidegib Topical Gel, 2%, | 47 | 87 |
| Total, other adverse events | Patidegib Topical Gel, Vehicle | 65 | 87 |
| Total, serious adverse events | Patidegib Topical Gel, 2%, | 5 | 87 |
| Total, serious adverse events | Patidegib Topical Gel, Vehicle | 7 | 87 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Patidegib Topical Gel, 2%, vs Patidegib Topical Gel, Vehicle: Percentage of Participants Developing >=2 Facial New BCCs | Trial comparisons |
| Patidegib Topical Gel, 2%, vs Patidegib Topical Gel, Vehicle: deaths from any cause | Trial comparisons |
| Patidegib Topical Gel, 2%, vs Patidegib Topical Gel, Vehicle: Percentage of Participants Developing >=1 Facial New BCCs | Trial comparisons |
| Patidegib Topical Gel, 2%, vs Patidegib Topical Gel, Vehicle: serious adverse events | Trial comparisons |
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/NCT03703310
GET https://conductscience.org/api/trials/v1/NCT03703310/events?page=2