A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

NCT ID: NCT02028286

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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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

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Conditions

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Papulopustular Rosacea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CLS001

CLS001

Group Type EXPERIMENTAL

CLS001

Intervention Type DRUG

Interventions

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CLS001

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maruho Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Frontage Clinical Services

Hackensack, New Jersey, United States

Site Status

Derm Research

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CLS001-CO-PR-002

Identifier Type: -

Identifier Source: org_study_id

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