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Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis (0405-01-04)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Product 0405
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis

Eligibility Criteria

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fougera Pharmaceuticals Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Product 0405

Arm Description

Topical Active Investigational Product 0405

Outcomes

Primary Outcome Measures

Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.

Secondary Outcome Measures

Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.

Full Information

First Posted
October 28, 2010
Last Updated
April 9, 2012
Sponsor
Fougera Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01232543
Brief Title
Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis
Acronym
0405-01-04
Official Title
An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fougera Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Product 0405
Arm Type
Experimental
Arm Description
Topical Active Investigational Product 0405
Intervention Type
Drug
Intervention Name(s)
Product 0405
Intervention Description
Product 0405 will be administered topically, twice daily for 28 days.
Primary Outcome Measure Information:
Title
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Ocasio, CCRA
Organizational Affiliation
Fougera Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Fougera Pharmaceuticals Inc.
City
Melville
State/Province
New York
ZIP/Postal Code
11747
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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