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Study of 0417 Ointment in the Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01139450
First received: June 7, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  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
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 0417 Ointment

Resource links provided by NLM:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean change from baseline in the total individual clinical signs and symptoms per body region [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • The mean change from baseline in pruritus [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]
  • The mean change from baseline in the percentage total body surface affected (%BSA) [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 900
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

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139450

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

No publications provided

Responsible Party: Ronald J. Trancik PhD/Senior Director, Clinical Research/Medical Affairs, Nycomed US Inc.
ClinicalTrials.gov Identifier: NCT01139450     History of Changes
Other Study ID Numbers: 0417
Study First Received: June 7, 2010
Last Updated: June 7, 2010
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
Dermatitis, Atopic
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013