Study of 0416 Ointment in the Treatment of Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01053247
First received: December 9, 2009
Last updated: June 16, 2014
Last verified: June 2014

December 9, 2009
June 16, 2014
January 2008
August 2009   (final data collection date for primary outcome measure)
Incidence of success based on the investigator's global evaluation at the end of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053247 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study of 0416 Ointment in the Treatment of Atopic Dermatitis
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel Group Study of 0416 Ointment.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: 0416
    Topical 0416 test product applied twice daily for 2 weeks
  • Drug: Vehicle of 0416 test product
    Vehicle of 0416 test product applied twice daily for 2 weeks
  • Drug: tacrolimus ointment 0.1%
    Reference Product for 0416 test product. Apply twice daily for 2 weeks.
  • Experimental: Test
    Test product that contains the active pharmaceutical ingredient
    Intervention: Drug: 0416
  • Active Comparator: Reference
    Reference product that contains active pharmaceutical ingredient
    Intervention: Drug: tacrolimus ointment 0.1%
  • Placebo Comparator: Vehicle
    Placebo that contains no active pharmaceutical ingredient
    Intervention: Drug: Vehicle of 0416 test product
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
793
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01053247
0416
No
Fougera Pharmaceuticals Inc.
Fougera Pharmaceuticals Inc.
Not Provided
Study Director: Angela C Kaplan Fougera Pharmaceuticals Inc.
Fougera Pharmaceuticals Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP