Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

NCT ID: NCT02176551

Last Updated: 2014-06-27

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

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.

Detailed Description

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Treatment medication will be administered topically twice daily for 28 days

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Product 0405

Topical active investigational Product 0405

Group Type EXPERIMENTAL

Product 0405

Intervention Type DRUG

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

Placebo for Product 0405

Topical Placebo for Product 0405

Group Type PLACEBO_COMPARATOR

Placebo for Product 0405

Intervention Type DRUG

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

Interventions

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Product 0405

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

Intervention Type DRUG

Placebo for Product 0405

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical Diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent body surface area minimum requirements

Exclusion Criteria

* Subjects who are pregnant, nursing or planning a pregnancy
Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fougera Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela C Kaplan

Role: STUDY_DIRECTOR

Fougera Pharmaceuticals Inc.

Other Identifiers

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0405-01-06

Identifier Type: -

Identifier Source: org_study_id

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