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

Maruho

Status and phase: Completed; Phase 3

Conditions: Rosacea

Treatments: Drug: CLS001 (Omiganan); Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576860

CLS001-CO-PR-005

Details and patient eligibility

About

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.

Enrollment: 263 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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263 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

CLS001 (Omignan) gel applied once daily

Treatment:

Drug: CLS001 (Omiganan)

Vehicle Gel

Placebo Comparator group

Description:

Vehicle gel applied once daily

Treatment:

Drug: Vehicle