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Trial record 7 of 51 for:    tazarotene

A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT02886715
Recruitment Status : Completed
First Posted : September 1, 2016
Results First Posted : August 17, 2018
Last Update Posted : August 17, 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 Acne Vulgaris
Interventions Drug: Tazarotene Cream 0.1%
Drug: Tazorac®
Drug: Placebo
Enrollment 1110
Recruitment Details At Baseline Visit eligible subjects were randomized to the Test, Reference or Placebo product in a 2:2:1 ratio using an interactive response technology (IRT) system
Pre-assignment Details

1154 subjects were screened for study participation, 1110 subjects were randomized and included in the statistical analyses.

25 investigative sites randomized subjects into the study.

Arm/Group Title Test Reference Placebo
Hide Arm/Group Description Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Period Title: Overall Study
Started [1] 442 445 223
Modified ITT (mITT) 421 418 217
Per Protocol (PP) Population 346 351 176
Completed 378 390 203
Not Completed 64 55 20
Reason Not Completed
Non-Compliance With Study Drug             0             2             0
Adverse Event             4             2             0
Lack of Efficacy             0             2             1
Lost to Follow-up             29             26             10
Pregnancy             1             1             1
Protocol Violation             3             2             1
Withdrawal by Subject             20             18             5
missing             7             2             2
[1]
Randomized - Safety Population
Arm/Group Title Test Reference Placebo Total
Hide Arm/Group Description Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.) Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.) Total of all reporting groups
Overall Number of Baseline Participants 442 445 223 1110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 442 participants 445 participants 223 participants 1110 participants
22.5  (7.0) 22.7  (7.0) 22.5  (7.0) 22.6  (7.0)
[1]
Measure Analysis Population Description: Started (Safety Population)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 442 participants 445 participants 223 participants 1110 participants
Female
236
  53.4%
215
  48.3%
96
  43.0%
547
  49.3%
Male
206
  46.6%
230
  51.7%
127
  57.0%
563
  50.7%
[1]
Measure Analysis Population Description: Started (Safety Population)
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 442 participants 445 participants 223 participants 1110 participants
Hispanic or Latino 265 252 130 647
Not Hispanic or Latino 177 193 93 463
[1]
Measure Analysis Population Description: Started (Safety Population)
1.Primary Outcome
Title Change in Inflammatory Lesion Counts
Hide Description Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts
Time Frame Week 12
Hide 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 0.1% (Fougera Pharmaceuticals Inc.)
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Overall Number of Participants Analyzed 421 418 217
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-58.44  (1.33) -60.07  (1.32) -53.28  (1.81)
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 for the least-squares mean Test/Reference ratios to be within 80-125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments p-value was no calculated
Method ANOVA
Comments with treatment and site as fixed effects in the model
Method of Estimation Estimation Parameter Test-to-Reference Ratio
Estimated Value 98.75
Confidence Interval (2-Sided) 90%
94.39 to 103.31
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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0185
Comments [Not Specified]
Method ANOVA
Comments with treatment and site as fixed effects in the model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.17
Confidence Interval (2-Sided) 95%
-9.46 to -0.87
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Non-inflammatory Lesion Counts
Hide Description Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts
Time Frame Week 12
Hide 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 0.1% (Fougera Pharmaceuticals Inc.)
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Overall Number of Participants Analyzed 421 418 217
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-50.11  (1.27) -51.99  (1.26) -45.72  (1.73)
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 for the least-squares mean Test/Reference ratios to be within 80-125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments p-value was no calculated
Method ANOVA
Comments with treatment and site as fixed effects in the model
Method of Estimation Estimation Parameter Test-to-Reference Ratio
Estimated Value 98.39
Confidence Interval (2-Sided) 90%
93.42 to 103.61
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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.0354
Comments [Not Specified]
Method ANOVA
Comments with treatment and site as fixed effects in the model
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.39
Confidence Interval (2-Sided) 95%
-8.48 to -0.30
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinical Response of Success
Hide Description The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description:
Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.)
TAZORAC® (tazarotene) Cream, 0.1% (Allergan, Inc.)
Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Overall Number of Participants Analyzed 421 418 217
Measure Type: Number
Unit of Measure: percentage of participants
20.0 23.7 15.2
Time Frame From baseline to week 12 (end of study)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description Tazarotene Cream 0.1% (Fougera Pharmaceuticals Inc.) TAZORAC® (tazarotene) Cream, 0.1% (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   0/442 (0.00%)      0/445 (0.00%)      0/223 (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   1/442 (0.23%)      0/445 (0.00%)      0/223 (0.00%)    
Psychiatric disorders       
Suicide attempt  1  1/442 (0.23%)  1 0/445 (0.00%)  0 0/223 (0.00%)  0
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   45/442 (10.18%)      57/445 (12.81%)      12/223 (5.38%)    
General disorders       
Application site dryness  1  11/442 (2.49%)  15/445 (3.37%)  2/223 (0.90%) 
Application site exfoliation  1  7/442 (1.58%)  8/445 (1.80%)  1/223 (0.45%) 
Application site pain  1  16/442 (3.62%)  9/445 (2.02%)  1/223 (0.45%) 
Application site pruritus  1  5/442 (1.13%)  10/445 (2.25%)  4/223 (1.79%) 
Infections and infestations       
Nasopharyngitis  1  5/442 (1.13%)  10/445 (2.25%)  2/223 (0.90%) 
Nervous system disorders       
Headache  1  7/442 (1.58%)  6/445 (1.35%)  3/223 (1.35%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  1/442 (0.23%)  9/445 (2.02%)  2/223 (0.90%) 
Rhinorrhoea  1  3/442 (0.68%)  7/445 (1.57%)  0/223 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Angela C Kaplan
Organization: Fougera Pharmaceuticals Inc.
Phone: 631-659-2256
EMail: angela.kaplan@sandoz.com
Layout table for additonal information
Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02886715     History of Changes
Other Study ID Numbers: 0454-01-01
0454 ( Other Identifier: Fougera Pharmaceuticals Inc. )
First Submitted: August 29, 2016
First Posted: September 1, 2016
Results First Submitted: May 31, 2018
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018