Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
Recruiting
Phase 3
Interventional Study
Acne Vulgaris
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 692 (estimated)
- Sponsor
- Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Industry
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About This Trial
The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflam…
Contacts
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