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Study of 0417 Ointment in the Treatment of Atopic Dermatitis

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.
ClinicalTrials.gov Identifier: NCT01139450
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : September 30, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: 0417
Drug: Vehicle of 0417 test product
Drug: Tacrolimus Ointment 0.03%
Enrollment 899
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test Reference Vehicle
Hide Arm/Group Description

Test product that contains the active pharmaceutical ingredient

Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks

Reference product that contains the active pharmaceutical ingredient

Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks

Period Title: Overall Study
Started 302 297 300
Completed 275 272 262
Not Completed 27 25 38
Reason Not Completed
Withdrawal by Subject             7             10             13
Lack of Efficacy             3             1             8
Protocol Violation             6             5             2
Lost to Follow-up             9             7             11
Administrative             0             0             1
Adverse Event             2             2             3
Arm/Group Title Test Reference Vehicle Total
Hide Arm/Group Description

Test product that contains the active pharmaceutical ingredient

Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks

Reference product that contains the active pharmaceutical ingredient

Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 302 297 300 899
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age, Years Number Analyzed 302 participants 297 participants 300 participants 899 participants
27.74  (18.11) 28.8  (18.99) 27.6  (17.34) 28.0  (18.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 297 participants 300 participants 899 participants
Female
186
  61.6%
194
  65.3%
186
  62.0%
566
  63.0%
Male
116
  38.4%
103
  34.7%
114
  38.0%
333
  37.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 302 participants 297 participants 300 participants 899 participants
United States 280 275 279 834
Central America 22 22 21 65
1.Primary Outcome
Title Incidence of Success Based on the Investigator’s Global Evaluation at the End of Treatment
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Reference Vehicle
Hide Arm/Group Description:

Test product that contains the active pharmaceutical ingredient

Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks

Reference product that contains the active pharmaceutical ingredient

Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks

Overall Number of Participants Analyzed 226 238 228
Measure Type: Number
Unit of Measure: participants
123 130 86
2.Secondary Outcome
Title The Mean Change From Baseline in the Total Individual Clinical Signs and Symptoms Per Body Region
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The Mean Change From Baseline in Pruritus
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Mean Change From Baseline in the Percentage Total Body Surface Affected (%BSA)
Hide Description [Not Specified]
Time Frame Baseline, 4 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Reference Vehicle
Hide Arm/Group Description

Test product that contains the active pharmaceutical ingredient

Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks

Reference product that contains the active pharmaceutical ingredient

Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks

All-Cause Mortality
Test Reference Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Reference Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/302 (0.33%)   0/297 (0.00%)   1/300 (0.33%) 
Cardiac disorders       
Severe Angina Pectoris  0/302 (0.00%)  0/297 (0.00%)  1/300 (0.33%) 
Infections and infestations       
Moderate Influenza  1/302 (0.33%)  0/297 (0.00%)  0/300 (0.00%) 
Reproductive system and breast disorders       
Ovarian Cyst  1/302 (0.33%)  0/297 (0.00%)  0/300 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Test Reference Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/302 (5.63%)   12/297 (4.04%)   20/300 (6.67%) 
General disorders       
Application site irritation  12/302 (3.97%)  11/297 (3.70%)  8/300 (2.67%) 
Skin and subcutaneous tissue disorders       
Dermatitis atopic  5/302 (1.66%)  1/297 (0.34%)  12/300 (4.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Angela C. Kaplan
Organization: Fougera Pharmaceuticals Inc.
Phone: 631-659-2256
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