A Phase 3 interventional study of Patidegib Topical Gel, 2% in Basal Cell Nevus Syndrome, sponsored by Sol-Gel Technologies, Ltd.. Terminated at 37 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Sol-Gel Technologies, Ltd. · Phase 3, Interventional, and Treatment
This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.
35 studies on the registry are indexed under Basal Cell Nevus Syndrome; 4 are open to participants now.
This study's enrollment of 108 is above the median of 24 across 25 interventional studies indexed under Basal Cell Nevus Syndrome.
Browse Basal Cell Nevus Syndrome 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patidegib Topical Gel, 2%
Drug: Patidegib Topical Gel, 2%
Patidegib Topical Gel, 2%
Incidence of Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: 12 months
Change in Number of Facial BCCs Removed by Surgery
Time frame: 12 months
Change in Number of New Lesions Suspicious for BCC
Time frame: 12 months
Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score
Time frame: 12 months
Change in Dermatology Life Quality Index (DLQI)
Time frame: 12 months
Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)
Time frame: 12 months
| Milestone | Patidegib Topical Gel, 2% |
|---|---|
| Started | 108 |
| Completed | 3 |
| Not completed | 105 |
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.
| Number of subjects | Patidegib Topical Gel, 2% |
|---|---|
| Number of subjects with at least one adverse event | 46 |
| Number of subjects with at least one adverse event related to IMP | 6 |
| Number of subjects with at least leading to treatment discontinuation | 0 |
| Number of subjects with at least one AE related to IMP leading to treatment discontinuation | 0 |
| Number of subjects with at least one paralesional adverse event | 3 |
| Number of subjects with at least one serious adverse event | 3 |
| Number of subjects with at least one serious adverse event related to IMP | 0 |
| Number of subjects withat least one adverse event leading to death | 0 |
| Number of subjects with at least one adverse event related to IMP leading to death | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
| Number of adverse events | Patidegib Topical Gel, 2% |
|---|---|
| Total number of adverse events | 82 |
| Number of unique adverse events | 72 |
Collected over 1 Year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patidegib Topical Gel, 2% | 0/105 (0%) | 3/105 (2.9%) | 46/105 (43.8%) |
| Event | Patidegib Topical Gel, 2% |
|---|---|
| Atrial fibrillationCardiac disorders | 1/105 |
| Craniocerebral injuryInjury, poisoning and procedural complications | 1/105 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/105 |
| Event | Patidegib Topical Gel, 2% |
|---|---|
| No adverse event occured in 5% or more of the patientsGeneral disorders | 46/105 |
| Age, Continuous(years) | Patidegib Topical Gel, 2%, |
|---|---|
| Mean | 53.9 ± 13.9 |
| Sex: Female, Male(Participants) | Patidegib Topical Gel, 2%, |
|---|---|
| Female | 59 |
| Male | 46 |
| Ethnicity (NIH/OMB)(Participants) | Patidegib Topical Gel, 2%, |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 84 |
| Unknown or Not Reported | 15 |
| Race (NIH/OMB)(Participants) | Patidegib Topical Gel, 2%, |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 8 |
| Black or African American | 0 |
| White | 87 |
| More than one race | 2 |
| Unknown or Not Reported | 8 |
| Height(cm) | Patidegib Topical Gel, 2%, |
|---|---|
| Mean | 175.9 ± 10.0 |
| Weight(kg) | Patidegib Topical Gel, 2%, |
|---|---|
| Mean | 93.1 ± 21.4 |
| BMI(kg/m2) | Patidegib Topical Gel, 2%, |
|---|---|
| Mean | 29.9 ± 6.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2020 to primary completion in Jul 2021, 13 months.
Results were first posted in Sep 2024, 3 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Patidegib Topical Gel
Sol-Gel Technologies, Ltd.