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

NCT02176551 | Withdrawn Phase 3

• 1 other identifier: 0405-01-06
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Statistically significant superiority of the test Product 0405 to the vehicle

  Statistically significant superiority of the test Product 0405 to the vehicle

  28 days

Secondary Outcomes (1)

• 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

Study Arms (2)

Product 0405

EXPERIMENTAL

Topical active investigational Product 0405

Drug: Product 0405

Placebo for Product 0405

PLACEBO COMPARATOR

Topical Placebo for Product 0405

Drug: Placebo for Product 0405

Interventions

Product 0405 DRUG

Product 0405 will be administered topically twice daily for 28 days.

Product 0405

Placebo for Product 0405 DRUG

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

Placebo for Product 0405

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical Diagnosis of Atopic Dermatitis
• Good health with the exception of Atopic Dermatitis
• Percent body surface area minimum requirements

You may not qualify if:

• Subjects who are pregnant, nursing or planning a pregnancy

Sponsors & Collaborators

• Fougera Pharmaceuticals Inc.: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Angela C Kaplan

  Fougera Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 27, 2014

Record last verified: 2014-06