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Trial record 22 of 90 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.


Reporting Groups
  Description
Test Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Reference TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Placebo Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)

Participant Flow:   Overall Study
    Test   Reference   Placebo
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 
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Test Tazarotene Cream 0.05% (Fougera Pharmaceuticals Inc.)
Reference TAZORAC® (tazarotene) Cream 0.05% (Allergan, Inc.)
Placebo Placebo (Vehicle of test product) (Fougera Pharmaceuticals Inc.)
Total Total of all reporting groups

Baseline Measures
   Test   Reference   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 284   286   285   855 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 53.5  (14.4)   53.7  (14.2)   52.7  (14.2)   53.3  (14.2) 
[1] Started (Safety Population)
Sex: Female, Male [1] 
[Units: Participants]
Count of 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] Started (Safety Population)
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of 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] Started (Safety Population)


  Outcome Measures

1.  Primary:   Treatment Success Assessed by IGA   [ Time Frame: Week 12 ]

2.  Secondary:   Disease Severity None or Minimal on IGA   [ Time Frame: Week 12 ]

3.  Secondary:   Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Angela C Kaplan
Organization: Fougera Pharmaceuticals Inc.
phone: 631-659-2256
e-mail: angela.kaplan@sandoz.com



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