Study of 0416 Ointment in the Treatment of Atopic Dermatitis
This study has been completed.
Sponsor:
Fougera Pharmaceuticals Inc.
Information provided by:
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01053247
First received: December 9, 2009
Last updated: January 20, 2010
Last verified: January 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
|
Eligibility| Ages Eligible for Study: | 18 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: NCT01053247
Locations
| United States, New York | |
| Nycomed US Inc. | |
| Melville, New York, United States, 11747 | |
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
| Study Director: | Ronald J Trancik, PhD | Fougera Pharmaceuticals Inc. |
More Information
No publications provided
| Responsible Party: | Ronald J. Trancik PhD/Senior Director, Clinical Research/Medical Affaris, Nycomed US Inc. |
| ClinicalTrials.gov Identifier: | NCT01053247 History of Changes |
| Other Study ID Numbers: | 0416 |
| Study First Received: | December 9, 2009 |
| Last Updated: | January 20, 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