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Study of 0417 Ointment in the Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139450
First Posted: June 8, 2010
Last Update Posted: October 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis Drug: 0417 Drug: Vehicle of 0417 test product Drug: Tacrolimus Ointment 0.03% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0417 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: 4 weeks ]

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

Enrollment: 899
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: 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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139450


Locations
United States, New York
Fougera Pharmaceuticals Inc.
Melville, New York, United States, 11747
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
  More Information

Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01139450     History of Changes
Other Study ID Numbers: 0417
First Submitted: June 7, 2010
First Posted: June 8, 2010
Results First Submitted: September 23, 2014
Results First Posted: September 30, 2014
Last Update Posted: October 9, 2014
Last Verified: September 2014

Keywords provided by Fougera Pharmaceuticals Inc.:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action