An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
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|ClinicalTrials.gov Identifier: NCT02682264|
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: CB-03-01 cream, 1%||Phase 3|
This is 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 will apply 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 will be 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 will treat facial acne per protocol for nine months. Treatment of truncal acne will be discussed by the investigator and participant. 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 (i.e., face and trunk).
Participants (approximately 600) will be 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||604 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 9, 2016|
|Actual Primary Completion Date :||August 31, 2018|
|Actual Study Completion Date :||August 31, 2018|
Experimental: CB-03-01 cream, 1%
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%
CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Other Name: cortexolone 17α-propionate
- Assessment of local and systemic safety and tolerability (Incidence of any local and systemic treatment emergent AEs) [ Time Frame: up to 52 weeks ]Incidence of any local and systemic treatment emergent AEs (TEAEs)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682264
|Study Director:||Alessandro Mazzetti, MD||Cassiopea SpA|