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Study of 0416 Ointment in the Treatment of Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01053247
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : October 3, 2014
Last Update Posted : October 3, 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: 0416
Drug: Vehicle of 0416 test product
Drug: tacrolimus ointment 0.1%
Enrollment 793
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 0.1% test product applied twice daily for 2 weeks

Reference product that contains active pharmaceutical ingredient

Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks

Period Title: Overall Study
Started 269 260 264
Completed 249 241 236
Not Completed 20 19 28
Reason Not Completed
Withdrawal by Subject             9             4             15
Lack of Efficacy             1             0             1
Protocol Violation             2             1             2
Lost to Follow-up             8             5             7
Adverse Event             0             9             3
Arm/Group Title Test Reference Vehicle Total
Hide Arm/Group Description

Test product that contains the active pharmaceutical ingredient

Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks

Reference product that contains active pharmaceutical ingredient

Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks

Total of all reporting groups
Overall Number of Baseline Participants 269 260 264 793
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 269 participants 260 participants 264 participants 793 participants
43.0  (16.29) 43.7  (16.74) 43.3  (17.14) 43.3  (16.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants 260 participants 264 participants 793 participants
Female
148
  55.0%
158
  60.8%
161
  61.0%
467
  58.9%
Male
121
  45.0%
102
  39.2%
103
  39.0%
326
  41.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 269 participants 260 participants 264 participants 793 participants
United States 258 253 255 766
Central America 11 7 9 27
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 2 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 0.1% test product applied twice daily for 2 weeks

Reference product that contains active pharmaceutical ingredient

Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks

Overall Number of Participants Analyzed 210 211 195
Measure Type: Number
Unit of Measure: participants
104 121 67
2.Secondary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame 2 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 0.1% test product applied twice daily for 2 weeks

Reference product that contains active pharmaceutical ingredient

Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks.

Placebo that contains no active pharmaceutical ingredient

Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 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   0/269 (0.00%)   0/260 (0.00%)   0/264 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.5%
Test Reference Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/269 (2.23%)   15/260 (5.77%)   8/264 (3.03%) 
General disorders       
Application Site Irritation  3/269 (1.12%)  6/260 (2.31%)  0/264 (0.00%) 
Application Site Pruritus  2/269 (0.74%)  8/260 (3.08%)  4/264 (1.52%) 
Skin and subcutaneous tissue disorders       
Atopic Dermatitis  1/269 (0.37%)  1/260 (0.38%)  4/264 (1.52%) 
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: NCT01053247     History of Changes
Other Study ID Numbers: 0416
First Submitted: December 9, 2009
First Posted: January 21, 2010
Results First Submitted: September 30, 2014
Results First Posted: October 3, 2014
Last Update Posted: October 3, 2014