A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

Maruho

Status and phase: Completed; Phase 1

Conditions: Papulopustular Rosacea

Treatments: Drug: CLS001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02028286

CLS001-CO-PR-002

Details and patient eligibility

About

The purpose of this study is to characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A diagnosis of papulopustular rosacea
• Grade 3 or 4 on the 5-point Investigator Global Assessment scale
• Presence of telangiectasia

Exclusion criteria

• steroid rosacea or subtype 3 (phymatous rosacea)
• clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject.
• nodular rosacea (lesions greater than 5mm with more than 2 modules)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

CLS001

Experimental group

Description:

CLS001

Treatment:

Drug: CLS001