An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris

Study Overview
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Brief Summary
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The primary objective of this study is to determine the long-term safety of CB-03-01 cream, 1% applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.

Detailed Description
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This was a multicenter, open label, long-term extension study for CB-03-01 cream, 1% focused on safety in male and female participants, 9 years or older who completed one of the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26]. Participants applies the active medication (CB-03-01 cream, 1%) twice daily to the entire face and, if designated by investigator AND desired by the participant, truncal acne for nine additional months of treatment. Thus, overall participants were exposed to CB-03-01 cream, 1% for a total treatment of up to 12 months (0 or 3 months in the Phase 3 pivotal study and an additional nine months in this long-term safety study). Participants treated facial acne per protocol for nine months. Treatment of truncal acne was discussed by the investigator and participant. Treatment on the face and/or trunk was discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area (i.e., face and trunk). Participants were rolled over from the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26] into this long-term, safety study in order to achieve at least 300 participants on-study at 6 months and 100 participants on-study at 12 months.

Official Title
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An Open-Label, Long-Term Extension Study to Evaluate the Safety of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice-Daily in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CB-03-01 cream, 1%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has successfully completed participation in one of the Phase 3 pivotal studies [CB-03-01/25 and CB-03-01/26]. Participant agrees to use effective method of contraception throughout study, if applicable. Participant has provided written informed consent or assent. Participant is willing to comply with study instructions and return to the clinic for required visits. Exclusion Criteria: Participant is pregnant, lactating, or is planning to become pregnant during the study. Participant has any skin disease or condition that could interfere with the safety evaluation of the test products or requires the use of interfering topical or systemic therapy. Participant has any condition which, in the investigator's opinion, would make it unsafe or unsuitable for the participant to participate in this research study. Participant plans to use any other investigational drug or device during participation in this study. Participant has known hypersensitivity or previous allergic reaction to the drug or any of its ingredients. Participant is or plans to use any restricted systemic and/or topical anti-acne preparations or medications during the study

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CB-03-01 cream, 1%<br>CB-03-01 (cortexolone 17α-propionate) Cream, 1%, applied twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area. | Drug: CB-03-01 cream, 1%<br>* Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.<br>* Other names: clascoterone (USAN, INN);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events | Number of participants with any local and systemic treatment emergent AEs (TEAEs) | up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acne, clascoterone, anti-androgen