NCT02176577

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

11 months

First QC Date

June 17, 2014

Last Update Submit

June 26, 2014

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Phamacokinetic sampling

    28 days

Secondary Outcomes (1)

  • Laboratory tests, vital signs, adverse events and local skin safety signs

    28 days

Study Arms (1)

Product 0405

EXPERIMENTAL

Topically Active Investigational Product 0405

Drug: Product 0405

Interventions

Product 0405DRUG

Product 0405 will be administered topically, twice daily for 28 days.

Product 0405

Eligibility Criteria

Age3 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Subject who are nursing, pregnant or planning a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Angela C Kaplan

    Fougera Pharmaceuticals Inc.

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 27, 2014

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 27, 2014

Record last verified: 2014-06