Study of 0416 Ointment in the Treatment of Atopic Dermatitis

This study has been completed.
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc. Identifier:
First received: December 9, 2009
Last updated: September 30, 2014
Last verified: September 2014

The aim of this trial is to assess the efficacy of 0416 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 2 weeks.

Condition Intervention Phase
Atopic Dermatitis
Drug: 0416
Drug: Vehicle of 0416 test product
Drug: tacrolimus ointment 0.1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.

Resource links provided by NLM:

Further study details as provided by Fougera Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Incidence of Success Based on the Investigator's Global Evaluation at the End of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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 and Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 793
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
Test product that contains the active pharmaceutical ingredient
Drug: 0416
Topical 0416 test product applied twice daily for 2 weeks
Active Comparator: Reference
Reference product that contains active pharmaceutical ingredient
Drug: tacrolimus ointment 0.1%
Reference Product for 0416 test product. Apply twice daily for 2 weeks.
Placebo Comparator: Vehicle
Placebo that contains no active pharmaceutical ingredient
Drug: Vehicle of 0416 test product
Vehicle of 0416 test product applied twice daily for 2 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01053247

United States, New York
Fougera Pharmaceuticals Inc.
Melville, New York, United States, 11747
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Study Director: Angela C Kaplan Fougera Pharmaceuticals Inc.
  More Information

Responsible Party: Fougera Pharmaceuticals Inc. Identifier: NCT01053247     History of Changes
Other Study ID Numbers: 0416 
Study First Received: December 9, 2009
Results First Received: September 30, 2014
Last Updated: September 30, 2014
Health Authority: United States: Institutional Review Board
Ecuador: Public Health Ministry
Panama: Ministry of Health
Dominican Republic: Consejo Nacional de Bioetica en Salud

Keywords provided by Fougera Pharmaceuticals Inc.:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic processed this record on May 24, 2016