Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Tacrolimus Ointment 0.03%; Drug: 0417; Drug: Vehicle of 0417 test product

• Registration Number: NCT01139450
• Lead Sponsor: Fougera Pharmaceuticals Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Disposition First Submitted: 2014-06-16
• Disposition First Submitted QC: 2014-06-16
• Disposition First Posted: 2014-06-19
• Status Verified: 2014-09
• Results First Submitted: 2014-09-23
• Results First Submitted QC: 2014-09-29
• Results First Posted: 2014-09-30
• Last Update Submitted: 2014-09-30
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 899

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference	Tacrolimus Ointment 0.03%	Reference product that contains the active pharmaceutical ingredient
Test	0417	Test product that contains the active pharmaceutical ingredient
Vehicle	Vehicle of 0417 test product	Placebo that contains no active pharmaceutical ingredient

Primary Outcome Measures

Name	Time	Method
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method
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 the Percentage Total Body Surface Affected (%BSA)	Baseline, 4 weeks
The Mean Change From Baseline in Pruritus	Baseline, 4 weeks

Trial Locations

Locations (1)

Fougera Pharmaceuticals Inc.; 🇺🇸 Melville, New York, United States