Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis

NCT ID: NCT01232543

Last Updated: 2012-04-11

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

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-11-30

Brief Summary

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The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis

Detailed Description

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Treatment medication will be administered topically, twice a day for 4 weeks.

Conditions

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Atopic Dermatitis

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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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.

Interventions

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Product 0405

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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Kathleen Ocasio, CCRA

Role: STUDY_DIRECTOR

Fougera Pharmaceuticals Inc.

Locations

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Fougera Pharmaceuticals Inc.

Melville, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0405-01-04

Identifier Type: -

Identifier Source: org_study_id

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