A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

Phase 1CompletedNCT02028286

Maruho Co., Ltd.25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Papulopustular Rosacea

Interventions

CLS001DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Frontage Clinical Services

Hackensack, New Jersey, United States

Derm Research

Austin, Texas, United States

Outcomes

Primary Outcomes

Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5

Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5.

Time frame: 24 days

Secondary Outcomes

incidence of adverse events

Time frame: 24 days

Data from ClinicalTrials.gov

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