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NCT02176551 Clinical Trial

Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

Atopic Dermatitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02176551
Other study ID # 0405-01-06
Secondary ID
Status Withdrawn
Phase Phase 3
First received June 17, 2014
Last updated June 26, 2014
Start date June 2012
Est. completion date May 2013

Study information
Verified date June 2014
Source Fougera Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.

Description:

Treatment medication will be administered topically twice daily for 28 days

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 17 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Product 0405
Product 0405 will be administered topically twice daily for 28 days.
• Placebo for Product 0405
Placebo for Product 0405 will be administered topically twice daily for 28 days.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fougera Pharmaceuticals Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Statistically significant superiority of the test Product 0405 to the vehicle Statistically significant superiority of the test Product 0405 to the vehicle 28 days No
Secondary Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment. 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 No
See also
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