- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02176577
Study to Determine the Pharmacokinetics of Product 0405
June 26, 2014 updated by: Fougera Pharmaceuticals Inc.
An Open-Label, Multi-Center Study to Determine the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects
The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects.
Study Overview
Detailed Description
Treament medication will be administered topically twice daily for 28 days.
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Product 0405
Topically Active Investigational Product 0405
|
Product 0405 will be administered topically, twice daily for 28 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phamacokinetic sampling
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Laboratory tests, vital signs, adverse events and local skin safety signs
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
May 1, 2013
Study Completion (Anticipated)
May 1, 2013
Study Registration Dates
First Submitted
June 17, 2014
First Submitted That Met QC Criteria
June 26, 2014
First Posted (Estimate)
June 27, 2014
Study Record Updates
Last Update Posted (Estimate)
June 27, 2014
Last Update Submitted That Met QC Criteria
June 26, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0405-01-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atopic Dermatitis
-
Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
SanofiCompletedAtopic Dermatitis | Dermatitis AtopicChina
-
SanofiCompletedDermatitis AtopicSaudi Arabia, Kuwait, United Arab Emirates
-
National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
Clinical Trials on Product 0405
-
Fougera Pharmaceuticals Inc.Withdrawn
-
Fougera Pharmaceuticals Inc.Withdrawn
-
Fougera Pharmaceuticals Inc.Completed
-
Pure Biologics S.A.Presage BiosciencesNot yet recruitingTriple Negative Breast Cancer | Head and Neck Squamous Cell Carcinoma | Soft Tissue Sarcoma Adult
-
British American Tobacco (Investments) LimitedCompletedTobacco Use | Tobacco SmokingUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco Use | Tobacco SmokingUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco Use | Tobacco Smoking | Smoking BehaviorsUnited States
-
RAI Services CompanyCompletedSmoking | Tobacco UseUnited States
-
Société des Produits Nestlé (SPN)Completed
-
British American Tobacco (Investments) LimitedCompletedTobacco Use | Tobacco Smoking | Cigarette SmokingUnited States