Back to resultsStudy to Determine the Pharmacokinetics of Product 0405
Primary Purpose
Atopic Dermatitis
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Product 0405
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Product 0405
Arm Description
Topically Active Investigational Product 0405
Outcomes
Primary Outcome Measures
Phamacokinetic sampling
Secondary Outcome Measures
Laboratory tests, vital signs, adverse events and local skin safety signs
Full Information
NCT ID
NCT02176577
First Posted
June 17, 2014
Last Updated
June 26, 2014
Sponsor
Fougera Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02176577
Brief Title
Study to Determine the Pharmacokinetics of Product 0405
Official Title
An Open-Label, Multi-Center Study to Determine the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Business Reasons
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Product 0405
Arm Type
Experimental
Arm Description
Topically 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
Phamacokinetic sampling
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Laboratory tests, vital signs, adverse events and local skin safety signs
Time Frame
28 days
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 minimums
Exclusion Criteria:
Subject who are nursing, pregnant or planning a pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela C Kaplan
Organizational Affiliation
Fougera Pharmaceuticals Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study to Determine the Pharmacokinetics of Product 0405
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