Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developin… (NCT03703310) | Clinical Trial Compass
CompletedPhase 3
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)
United States174 participantsStarted 2019-02-19
Plain-language summary
This is a global, 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 Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The participant must be age at least 18 years of age at the Screening Visit.
✓. The participant must provide written informed consent prior to any study procedures.
✓. The participant must meet diagnostic criteria for the basal cell nevus (Gorlin) syndrome including major criterion #3a plus 1 additional major criterion or plus 2 additional minor criteria listed below.
✓. \>2 histologically confirmed BCCs or 1 for participant under age 20.
✓. Odontogenic keratocysts of the jaw confirmed histologically.
✓. ≥3 palmar and/or plantar pits seen at the Screening Visit.
✓. Bilamellar calcification of the falx cerebri present at less than 20 years of age.
✓. Fused, bifid, or markedly splayed ribs.
Exclusion criteria
✕. The subject has previously participated in a clinical trial evaluating patidegib topical gel.
✕. The participant has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP. Among these are use of the following:
✕. 5-fluorouracil, imiquimod, diclofenac, or Ingenol mebutate (except as topical treatment to discrete non-facial BCCs) systemically or topically to the skin within the 2 months prior to the Screening Visit.
. Systemic chemotherapy within 1 year prior to the Screening Visit.
✕. Known inhibitors of the Hedgehog signaling pathway (such as vismodegib, sonidegib, itraconazole) topically or systemically within 3 months prior to the Screening Visit.
✕. Photodynamic therapy (PDT) except to localized non-facial, individual BCCs within 2 months prior to the Screening Visit.
✕. The participant is known to have a hypersensitivity to any of the ingredients in the study medication formulation.
✕. The participant is unable or unwilling to make a good faith effort to return to the study site for all study visits and tests.