Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment

The aim of this trial is to assess the efficacy of 0417 Ointment in the Treatment of Atopic Dermatitis.

Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 4 weeks.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: 0417; Drug: Tacrolimus Ointment 0.03%; Drug: Vehicle of 0417 test product

• Study Type: Interventional
• Enrollment (Actual): 899
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Melville, New York, United States, 11747
      • Fougera Pharmaceuticals Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• 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 within the study participation period.
• Subjects who have any systemic or dermatological disorders with the exception of Atopic Dermatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Placebo that contains no active pharmaceutical ingredient	Drug: Vehicle of 0417 test product; Vehicle of 0417 test product applied twice daily for 4 weeks
Experimental: Test; Test product that contains the active pharmaceutical ingredient	Drug: 0417; Topical 0417 test product applied twice daily for 4 weeks
Active Comparator: Reference; Reference product that contains the active pharmaceutical ingredient	Drug: Tacrolimus Ointment 0.03%; Reference product for 0417 test product. Apply twice daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region	Baseline, 4 weeks
The Mean Change From Baseline in Pruritus	Baseline, 4 weeks
The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)	Baseline, 4 weeks

Collaborators and Investigators

• Sponsor: Fougera Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 7, 2010
• First Posted (Estimate): June 8, 2010

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: September 30, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Atopic Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 0417