A 21 Day Pharmacokinetics Study in Papulopustular Rosacea | NCT02028286

Studies
A 21 Day Pharmacokinetics Study in Papulopustular Rosacea

NCT02028286

Sponsor

Maruho Co., Ltd.

Status

Completed

Last Update Posted

Apr 14, 2014Estimated

Enrollment

25Actual

Phase

Phase 1

Conditions

Papulopustular Rosacea

Interventions

CLS001

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Mar 2014Actual

Completion Date

Not provided

First Submitted Date

Nov 27, 2013

First Submission Date that Met QC Criteria

Jan 3, 2014

First Posted Date

Jan 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2014

Last Update Posted Date

Apr 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
CLS001	Experimental	CLS001	Drug: CLS001

Name	Type	Description	Arm Group Labels	Other Names
CLS001	Drug		CLS001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	24 days

Secondary Outcomes

Measure	Description	Time Frame
incidence of adverse events		24 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frontage Clinical Services		Hackensack	New Jersey	07601	United States
Derm Research

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided