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Trial record 22 of 92 for:    cream | "Psoriasis"

A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02886702
Recruitment Status : Completed
First Posted : September 1, 2016
Results First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Tazarotene Cream 0.05%
Drug: TAZORAC® (tazarotene) Cream 0.05%
Drug: Placebo
Enrollment 855
Recruitment Details At Visit 1, eligible subjects were randomized to the Test, Reference or Placebo product in a 1:1:1 ratio using an interactive response technology (IRT) system.
Pre-assignment Details

927 subjects were screened for study participation, 855 subjects were randomized and included in the statistical analyses.

29 investigative sites (one with two locations) randomized subjects into the study.

Arm/Group Title Test Reference Placebo
Hide Arm/Group Description Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Period Title: Overall Study
Started [1] 284 286 285
Modified Intent-to Treat (mITT) [2] 263 266 275
Per-Protocol Population (PP) [3] 208 209 201
Completed 236 235 232
Not Completed 48 51 53
Reason Not Completed
Not Specified             4             3             9
Withdrawal by Subject             24             18             22
Significant Worsening of Condition             0             1             0
Protocol Violation             2             2             1
Non-Compliance With Study Drug             0             1             4
Lost to Follow-up             11             13             8
Lack of Efficacy             3             4             5
Adverse Event             4             9             3
Administrative Reasons             0             0             1
[1]
Randomized (Safety Population)
[2]
met all inclusion/exclusion criteria, received study treatment, and had a post-Baseline evaluation
[3]
all randomized subjects who complied with the protocol
Arm/Group Title Test Reference Placebo Total
Hide Arm/Group Description Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) Total of all reporting groups
Overall Number of Baseline Participants 284 286 285 855
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 284 participants 286 participants 285 participants 855 participants
53.5  (14.4) 53.7  (14.2) 52.7  (14.2) 53.3  (14.2)
[1]
Measure Analysis Population Description: Started (Safety Population)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 286 participants 285 participants 855 participants
Female
142
  50.0%
129
  45.1%
155
  54.4%
426
  49.8%
Male
142
  50.0%
157
  54.9%
130
  45.6%
429
  50.2%
[1]
Measure Analysis Population Description: Started (Safety Population)
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 284 participants 286 participants 285 participants 855 participants
Hispanic or Latino
172
  60.6%
168
  58.7%
174
  61.1%
514
  60.1%
Not Hispanic or Latino
112
  39.4%
118
  41.3%
111
  38.9%
341
  39.9%
[1]
Measure Analysis Population Description: Started (Safety Population)
1.Primary Outcome
Title Treatment Success Assessed by IGA
Hide Description Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the "Investigator’s Global Assessment of Disease Severity" (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT for superiority versus placebo, PP for equivalence versus Reference
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description:
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Overall Number of Participants Analyzed 263 266 275
Measure Type: Number
Unit of Measure: Percentage of Participants
60.8 63.2 56.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Reference
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments 90% confidence interval on the difference between the proportions to be within [-20%, +20%].
Statistical Test of Hypothesis P-Value [Not Specified]
Comments p-value not calculated
Method Yates’ corrected confidence interval
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -4.5
Confidence Interval 90%
-12.6 to 3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Last Observation Carried Forward (LOCF) for missing efficacy values
Statistical Test of Hypothesis P-Value 0.3520
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments stratified by clinical site
2.Secondary Outcome
Title Disease Severity None or Minimal on IGA
Hide Description Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description:
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Overall Number of Participants Analyzed 263 266 275
Measure Type: Number
Unit of Measure: Percentage of Participants
17.5 22.6 16.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8105
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments stratified by clinical site
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reference, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0613
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments stratified by clinical site
3.Secondary Outcome
Title Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI
Hide Description Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description:
Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Overall Number of Participants Analyzed 263 266 275
Measure Type: Number
Unit of Measure: Percentage of Participants
16.3 22.2 16.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments stratified by clinical site
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reference, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0712
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments stratified by clinical site
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 85 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.) TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.) Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
All-Cause Mortality
Test Reference Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/284 (0.00%)      0/286 (0.00%)      0/285 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Test Reference Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/284 (0.00%)      0/286 (0.00%)      3/285 (1.05%)    
Cardiac disorders       
Acute myocardial infarction  1  0/284 (0.00%)  0 0/286 (0.00%)  0 1/285 (0.35%)  1
Metabolism and nutrition disorders       
Hypokalaemia  1  0/284 (0.00%)  0 0/286 (0.00%)  0 1/285 (0.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Prostate cancer  1  0/284 (0.00%)  0 0/286 (0.00%)  0 1/285 (0.35%)  1
Renal and urinary disorders       
Ischaemic nephropathy  1  0/284 (0.00%)  0 0/286 (0.00%)  0 1/285 (0.35%)  1
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/284 (0.00%)  0 0/286 (0.00%)  0 1/285 (0.35%)  1
Hypoxia  1  0/284 (0.00%)  0 0/286 (0.00%)  0 1/285 (0.35%)  1
Pulmonary embolism  1  0/284 (0.00%)  0 0/286 (0.00%)  0 1/285 (0.35%)  1
1
Term from vocabulary, MedDRA Version 19.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Test Reference Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/284 (10.92%)      24/286 (8.39%)      21/285 (7.37%)    
General disorders       
Application site dryness  1  2/284 (0.70%)  4/286 (1.40%)  2/285 (0.70%) 
Application site erosion  1  5/284 (1.76%)  4/286 (1.40%)  6/285 (2.11%) 
Application site erythema  1  5/284 (1.76%)  5/286 (1.75%)  4/285 (1.40%) 
Application site pain  1  9/284 (3.17%)  9/286 (3.15%)  10/285 (3.51%) 
Application site pruritus  1  8/284 (2.82%)  4/286 (1.40%)  4/285 (1.40%) 
Application site rash  1  2/284 (0.70%)  5/286 (1.75%)  1/285 (0.35%) 
Infections and infestations       
Nasopharyngitis  1  5/284 (1.76%)  2/286 (0.70%)  3/285 (1.05%) 
Sinusitis  1  0/284 (0.00%)  1/286 (0.35%)  3/285 (1.05%) 
Nervous system disorders       
Headache  1  6/284 (2.11%)  2/286 (0.70%)  3/285 (1.05%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/284 (0.70%)  3/286 (1.05%)  1/285 (0.35%) 
1
Term from vocabulary, MedDRA Version 19.1
Indicates events were collected by systematic assessment
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.
The terms and conditions of Fougera' agreements with its investigators may vary. However, Fougera does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
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: NCT02886702     History of Changes
Other Study ID Numbers: 0453-01-01
0453 ( Other Identifier: Fougera Pharmaceuticals Inc. )
First Submitted: August 29, 2016
First Posted: September 1, 2016
Results First Submitted: July 30, 2018
Results First Posted: August 29, 2018
Last Update Posted: August 29, 2018