A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

Phase 1

Completed

• Conditions: Papulopustular Rosacea
• Interventions: Drug: CLS001

• Registration Number: NCT02028286
• Lead Sponsor: Maruho Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-27
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Primary Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLS001	CLS001	CLS001

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5	24 days	Plasma concentrations of CLS001 to determine pharmacokinetic parameters at visit 2, visit 3 and visit 5.

Secondary Outcome Measures

Name	Time	Method
incidence of adverse events	24 days

Trial Locations

Locations (2)

Frontage Clinical Services; 🇺🇸 Hackensack, New Jersey, United States

Derm Research; 🇺🇸 Austin, Texas, United States