A Twelve Week Safety and Efficacy Study in Rosacea

Maruho

Status and phase: Completed; Phase 2

Conditions: Papulopustular Rosacea

Treatments: Drug: placebo; Drug: omiganan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01784133

CLS001-CO-PR-001

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups, including a placebo group

omiganan mid dose

Active Comparator group

Description:

omiganan mid dose once daily application for 12 weeks

Treatment:

Drug: omiganan

omiganan high dose

Active Comparator group

Description:

omiganan high dose once daily application for 12 weeks

Treatment:

Drug: omiganan

Vehicle group

Placebo Comparator group

Description:

Vehicle once daily application for 12 weeks

Treatment:

Drug: placebo

omiganan low dose

Active Comparator group

Description:

omiganan low dose once daily application for 12 weeks

Treatment:

Drug: omiganan