A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Omiganan (CLS001) Topical Gel; Drug: Vehicle Topical Gel

• Registration Number: NCT02571998
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-03
• Disposition First Submitted: 2017-03-24
• Disposition First Submitted QC: 2017-03-24
• Last Update Submitted: 2017-03-24
• Disposition First Posted: 2017-03-27
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

• Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
• Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
• Subjects with ≥ 30 facial inflammatory lesions

Exclusion Criteria

• Subjects with < 10 or > 75 facial non-inflammatory lesions
• Subjects with > 3 facial nodular or cystic lesions at Baseline
• Standard exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Omiganan (CLS001) Topical Gel	Omiganan (CLS001) Topical Gel applied once daily
Vehicle Gel	Vehicle Topical Gel	Vehicle Topical Gel applied once daily

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in inflammatory lesion counts at week 12	12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit	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.	12 weeks
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions	12 weeks
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit	12 weeks