IRB #

STUDY00019384

Title

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PHASE 3 EFFICACY AND SAFETY 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

Principal Investigator

Anna Bar

Study Purpose

We are doing this study because we want to find out if patidegib topical gel (referred to as the study gel) is beneficial and safe in reducing Basal Cell Carcinomas (BCC) in people with Basal Cell Nevus Syndrome (BCNS).

Medical Condition(s)

Basal Cell Carcinomas (BCC), Basal Cell Nevus Syndrome (BCNS)

Eligibility Criteria

Must be 18 years of age;
Must have had at least 10 (with at least 3 on the face) BCCs present within 24 months prior to enrollment;
Woman of child bearing potential (WOCBP), must be willing to use complete abstinence from sexual intercourse and/or she and her partner Must be willing to use at least 2 highly-effective forms of birth;
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;
Must be willing to have blood collected

Other criteria will be discussed with the study team/investigator

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

14.5 Months

Minors Included

No

Contact

503-494-4770
dermtrials@ohsu.edu

Sponsor

PellePharm, Inc

Recruitment End

12/24/2019

Compensation Provided

No


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