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Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755196
First Posted: September 18, 2008
Last Update Posted: March 6, 2017
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.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: January 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: AN2728
Drug: Ointment vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AN2728 5 Percent (%) Ointment + Ointment Vehicle AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.

Participant Flow:   Overall Study
    AN2728 5 Percent (%) Ointment + Ointment Vehicle
STARTED   30 
COMPLETED   28 
NOT COMPLETED   2 
Lost to Follow-up                1 
Lack of Efficiency                1 



  Baseline Characteristics
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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.
Intent-to-treat (ITT) population included all randomized participants who received the study medication.

Reporting Groups
  Description
AN2728 5% Ointment + Ointment Vehicle AN2728 5 % ointment and ointment vehicle were applied to 2 comparable and anatomically distinct treatment-targeted plaques, respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.

Baseline Measures
   AN2728 5% Ointment + Ointment Vehicle 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.4  (8.63) 
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      30 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) at Day 84   [ Time Frame: Day 84 ]

2.  Secondary:   Percentage of Participants With Lowering of Overall Target Plaque Severity Score (OTPSS) At Day 7, 14, 28, 42, 56, 70, 91   [ Time Frame: Day 7, 14, 28, 42, 56, 70, 91 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer,Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00755196     History of Changes
Other Study ID Numbers: AN2728-PSR-202
C3291015 ( Other Identifier: Pfizer )
First Submitted: September 17, 2008
First Posted: September 18, 2008
Results First Submitted: January 12, 2017
Last Update Posted: March 6, 2017