Study to Determine the Pharmacokinetics of Product 0405 | NCT02176577

Studies
Study to Determine the Pharmacokinetics of Product 0405

NCT02176577

Sponsor

Fougera Pharmaceuticals Inc.

Status

Withdrawn

Last Update Posted

Jun 27, 2014Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Atopic Dermatitis

Interventions

Product 0405

Countries

Not provided

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business Reasons

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

May 2013Estimated

Completion Date

May 2013Estimated

First Submitted Date

Jun 17, 2014

First Submission Date that Met QC Criteria

Jun 26, 2014

First Posted Date

Jun 27, 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

Jun 26, 2014

Last Update Posted Date

Jun 27, 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 evaluate the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects.

Detailed Description

Treament medication will be administered topically twice daily for 28 days.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Product 0405	Experimental	Topically Active Investigational Product 0405	Drug: Product 0405

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Product 0405	Drug	Product 0405 will be administered topically, twice daily for 28 days.	Product 0405

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phamacokinetic sampling		28 days

Secondary Outcomes

Measure	Description	Time Frame
Laboratory tests, vital signs, adverse events and local skin safety signs		28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Atopic Dermatitis
Good health with the exception of Atopic Dermatitis
Percent body surface area minimums

Exclusion Criteria:

Subject who are nursing, pregnant or planning a pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Angela C Kaplan	Fougera Pharmaceuticals Inc.	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided