A Phase 2 interventional study of Omiganan (CLS001) Topical Gel and Vehicle Topical Gel in Acne Vulgaris, sponsored by Maruho Co., Ltd.. Completed at 29 sites in United States. Open to female participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-03-27.
Sponsored by Maruho Co., Ltd. · Phase 2, Interventional, and Treatment
The primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
730 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.
This study's enrollment of 320 is above the median of 68 across 627 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Maruho Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Omiganan (CLS001) Topical Gel applied once daily
Drug: Omiganan (CLS001) Topical Gel
Vehicle Topical Gel applied once daily
Drug: Vehicle Topical Gel
Absolute change from baseline in inflammatory lesion counts at week 12
Time frame: 12 weeks
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions
Time frame: 12 weeks
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit
Time frame: 12 weeks
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit
Time frame: 12 weeks
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.
Time frame: 12 weeks
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Maruho Co., Ltd.