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

Maruho Co., Ltd.463 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

463

Conditions

Rosacea

Interventions

CLS001 (Omiganan)DRUG

Topical gel

VehicleDRUG

Vehicle Gel

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (41)

Unnamed facility

Outcomes

Primary Outcomes

Change in Inflammatory Lesion Count From Baseline to Week 12

Change from Baseline to Week 12 in Inflammatory Lesion Count

Time frame: 12 weeks

Percentage of Participants Who Achieved 2 Grade IGA Reduction.

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).

Time frame: 12 weeks

Secondary Outcomes

Change in the Number of Inflammatory Lesions From Baseline at Week 9

The absolute change in inflammatory lesions from baseline to Week 9

Time frame: 9 weeks

Change in the Number of Inflammatory Lesions From Baseline at Week 6

The absolute change in inflammatory lesions from baseline to Week 6

Time frame: 6 weeks

Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.

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).

Time frame: 9 Weeks

Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.

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).

Time frame: 6 Weeks

Data from ClinicalTrials.gov

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