Pelle-926-203 Study, a research study for adults 18 years of age and older with High Frequency Basal Cell Carcinoma.

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

A multicenter, randomized, double-blind, vehicle-controlled, phase 2 efficacy and safety study of Patidegib Topical Gel, 2% for adults with high frequency Basal Cell Carcinoma (HF-BCC) who are 18 years of age and older at the time of study enrollment. 

The study comprises three periods: screening, treatment, and follow-up. Participation in this study will last approximately 10.5 months.

Description

The purpose of the study is to determine the safety and effectiveness of an investigational topical gel for the reduction of facial Basal Cell Carcinomas requiring surgery in people living with HF-BCC.

Details
Condition Basal cell carcinoma, Skin Cancer
Clinical Study IdentifierTX233893
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject must be at least 18 years old at the Screening Visit
The subject must have had at least 10 (with at least 3 on the face) clinically typical BCCs present within 24 months prior to Screening and Randomization (Baseline/Day 1). Additionally, the subject must have at least 2 BCCs with longest diameter < 5 mm present on the face prior to Screening and Randomization (Baseline/Day 1)
The subject must be willing to have blood collected to measure circulating drug levels
The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Moisturizers and emollients are allowed. Subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (SPF) of at least 30, daily, on all exposed skin sites

Exclusion Criteria

The subject has been previously diagnosed with Gorlin syndrome
On medical history, family history, or clinical examination there is a suspicion that the patient has Gorlin syndrome
Patients with a family history of medulloblastoma
The subject has previously participated in a clinical trial evaluating patidegib topical gel
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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