An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17a-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects with Acne Vulgaris - not available

CASSIOPEA SpA0 sites609 target enrollmentMay 20, 2016

Overview

No summary available.

Registry

who.int

Start Date

May 20, 2016

End Date

August 31, 2018

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Subject must have been enrolled in one of the Phase 3 pivotal studies (CB\-03\-01/25 and CB\-03\-01/26\), completed the assigned
•treatment regimen without any material non\-compliance with study requirements or test article dosing (compliance \=80%), and
•completed the final study visit (Visit 4\-Pivotal).
•2\. Subject agrees to treat his/her facial acne and truncal acne (if designated by investigator AND desired by subject) during the
•nine month study period per protocol. Note: Subjects who are clear (IGA\=0\) at Visit 4\-Pivotal are also eligible for this study.
•3\. Females must be post\-menopausal1, surgically sterile2, or using highly effective birth control methods.3,4 Women of
•childbearing potential (WOCBP)5 must have a negative urine pregnancy test (UPT) at Visit 4\-LTF (or Visit 4\-Pivotal, if the visits
•occur on the same day).
•4\. Subject has provided written informed consent/assent. A subject under 18 years of age must provide written informed assent
•and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must

•1\. Subject is pregnant, lactating, or is planning to become pregnant during the study.
•2\. Subject has any skin pathology or condition that could interfere with the safety evaluation of the test products or requires the
•use of interfering topical or systemic therapy (see Section 8\.1: Prohibited Medications and Therapies).
•3\. Subject has any condition which, in the investigator’s opinion, would make it unsafe or unsuitable for the subject to participate
•in this research study.
•4\. Subject plans to use any other investigational drug or device during participation in this study.
•5\. Subject, and parent/guardian if required, is unable to communicate or cooperate with the investigator due to language
•problems, poor mental development, or impaired cerebral function.
•6\. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subject who
•is unable to return for scheduled follow\-up visits.