NCT01784133
Completed
Phase 2
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
Overview
- Phase
- Phase 2
- Intervention
- omiganan
- Conditions
- Papulopustular Rosacea
- Sponsor
- Maruho Co., Ltd.
- Enrollment
- 240
- Locations
- 17
- Primary Endpoint
- Change in inflammatory lesion count
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosis of papulopustular rosacea (at least 15 lesions)
Exclusion Criteria
- •nodular rosacea or subtype 3
- •clinically significant abnormal findings that would interfere with study objectives
Arms & Interventions
omiganan mid dose
omiganan mid dose once daily application for 12 weeks
Intervention: omiganan
omiganan high dose
omiganan high dose once daily application for 12 weeks
Intervention: omiganan
Vehicle group
Vehicle once daily application for 12 weeks
Intervention: placebo
omiganan low dose
omiganan low dose once daily application for 12 weeks
Intervention: omiganan
Outcomes
Primary Outcomes
Change in inflammatory lesion count
Time Frame: 0, 1, 3, 6, 9 and 12 weeks
Secondary Outcomes
- Success on IGA defined as clear or almost clear(Week 12)
Study Sites (17)
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