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Study of 0417 Ointment in the Treatment of Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0417
Vehicle of 0417 test product
Tacrolimus Ointment 0.03%
Sponsored by
Fougera Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fougera Pharmaceuticals Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test

Reference

Vehicle

Arm Description

Test product that contains the active pharmaceutical ingredient

Reference product that contains the active pharmaceutical ingredient

Placebo that contains no active pharmaceutical ingredient

Outcomes

Primary Outcome Measures

Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment

Secondary Outcome Measures

The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region
The Mean Change From Baseline in Pruritus
The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)

Full Information

First Posted
June 7, 2010
Last Updated
September 30, 2014
Sponsor
Fougera Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01139450
Brief Title
Study of 0417 Ointment in the Treatment of Atopic Dermatitis
Official Title
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 Ointment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fougera Pharmaceuticals Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
899 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Test product that contains the active pharmaceutical ingredient
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
Reference product that contains the active pharmaceutical ingredient
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo that contains no active pharmaceutical ingredient
Intervention Type
Drug
Intervention Name(s)
0417
Intervention Description
Topical 0417 test product applied twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Vehicle of 0417 test product
Intervention Description
Vehicle of 0417 test product applied twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Tacrolimus Ointment 0.03%
Intervention Description
Reference product for 0417 test product. Apply twice daily for 4 weeks
Primary Outcome Measure Information:
Title
Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region
Time Frame
Baseline, 4 weeks
Title
The Mean Change From Baseline in Pruritus
Time Frame
Baseline, 4 weeks
Title
The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)
Time Frame
Baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fougera Pharmaceuticals Inc.
City
Melville
State/Province
New York
ZIP/Postal Code
11747
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of 0417 Ointment in the Treatment of Atopic Dermatitis

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