- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02176551
Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects
June 26, 2014 updated by: Fougera Pharmaceuticals Inc.
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Product 0405 To A Vehicle Control In The Treatment Of Mild To Moderate Atopic Dermatitis In Pediatric Subjects
The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Treatment 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 minimum requirements
Exclusion Criteria:
- Subjects who are pregnant, nursing 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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Product 0405
Topical active investigational Product 0405
|
Product 0405 will be administered topically twice daily for 28 days.
|
Placebo Comparator: Placebo for Product 0405
Topical Placebo for Product 0405
|
Placebo for Product 0405 will be administered topically twice daily for 28 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Statistically significant superiority of the test Product 0405 to the vehicle
Time Frame: 28 days
|
Statistically significant superiority of the test Product 0405 to the vehicle
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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: 28 days
|
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.
|
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
- 0405-01-06
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.
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