Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle

Study Overview
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Brief Summary
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This study evaluates the safety and efficacy of once-daily application of CLS001 topical gel compared to vehicle gel in subjects with severe papulopustular rosacea.

Official Title
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A Phase 3, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily CLS001 Topical Gel Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea With a 4 Week Follow-up Period

Conditions
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Rosacea

Intervention / Treatment
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* Drug: CLS001 (Omiganan)
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, male and non-pregnant female subjects, 18 years of age or older. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline. Subjects with the presence of telangiectasia at Baseline. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline. Exclusion Criteria: Subjects with steroid rosacea or subtype 3 (phymatous rosacea). Subjects with nodular rosacea. Standard exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>CLS001 (Omignan) gel applied once daily | Drug: CLS001 (Omiganan)<br>* Topical gel<br>|
| Placebo Comparator: Vehicle Gel<br>Vehicle gel applied once daily | Drug: Vehicle<br>* Vehicle gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Absolute Change in Inflammatory Lesion Count | Absolute change in inflammatory lesion count from baseline to Week 12. | 12 weeks | 
| Efficacy IGA: 2 Grade Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy The Absolute Change in Inflammatory Lesions | The absolute change in inflammatory lesions from baseline to Week 9. | 9 weeks | 
| Efficacy The Absolute Change in Inflammatory Lesions | The absolute change in inflammatory lesions from baseline to Week 6. | 6 weeks | 
| Efficacy IGA: 2 Point Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | 9 Weeks | 
| Efficacy IGA: 2 Point Reduction | Proportion of Subjects Who Achieved 2 Grade IGA Reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe). | 6 Weeks |