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

Phase 3

Completed

• Conditions: Rosacea
• Interventions: Drug: CLS001 (Omiganan); Drug: Vehicle

• Registration Number: NCT02547441
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-11
• Study Start: 2015-12
• Primary Completion: 2017-07-05
• Study Completion: 2018-04-13
• Disposition First Submitted: 2018-07-05
• Disposition First Submitted QC: 2018-07-05
• Disposition First Posted: 2018-07-09
• Results First Submitted: 2022-06-13
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-31
• Last Update Submitted: 2022-07-31
• Results First Posted: 2022-08-02
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

1. Healthy, male and non-pregnant female subjects, 18 years of age or older.
2. A diagnosis of papulopustular rosacea with ≥30 inflammatory facial lesions at Baseline. Subjects must have no more than 2 nodular lesions, at Baseline.
3. Subjects with the presence of telangiectasia at Baseline.
4. Subjects with an erythema score of at least 2 on the Investigator Assessment of Erythema scale at Baseline.
5. Subjects with severe rosacea on the Investigators Global Assessment scale at Baseline.

Exclusion Criteria

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea.
3. Standard exclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Inflammatory Lesion Count From Baseline to Week 12	12 weeks	Change from Baseline to Week 12 in Inflammatory Lesion Count
Percentage of Participants Who Achieved 2 Grade IGA Reduction.	12 weeks	Percentage of participants who achieved 2 grade IGA reduction at Week 12. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.	9 Weeks	Percentage of participants who achieved 2 grade IGA reduction at Week 9. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).
Change in the Number of Inflammatory Lesions From Baseline at Week 9	9 weeks	The absolute change in inflammatory lesions from baseline to Week 9
Change in the Number of Inflammatory Lesions From Baseline at Week 6	6 weeks	The absolute change in inflammatory lesions from baseline to Week 6
Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.	6 Weeks	Percentage of participants who achieved 2 grade IGA reduction at Week 6. IGA scores are from 0 to 5 (Clear, Almost Clear, Mild, Moderate and Severe).