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Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis (PPP)

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01090063
First received: March 15, 2010
Last updated: January 31, 2013
Last verified: January 2013
Results First Received: August 13, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Moderate to Severe Palmar Plantar Psoriasis
Intervention: Drug: Ustekinumab

  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
Recruitment from Apr 2010 to Sept 2011 in the dermatology clinic of a tertiary care hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Washout of 2 weeks for topicals, 4 weeks for all other biologics and systemics prior to baseline dosage.

Reporting Groups
  Description
Main All participants were treated the same

Participant Flow for 2 periods

Period 1:   Screen
    Main  
STARTED     28  
COMPLETED     24  
NOT COMPLETED     4  
Screen Failed                 4  

Period 2:   Treatment
    Main  
STARTED     24  
COMPLETED     20  
NOT COMPLETED     4  
Withdrawal by Subject                 4  



  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.
No text entered.

Reporting Groups
  Description
Main No text entered.

Baseline Measures
    Main  
Number of Participants  
[units: participants]
  24  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     18  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  55  ± 16  
Gender  
[units: participants]
 
Female     14  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16.   [ Time Frame: 16 weeks ]

2.  Secondary:   PGA Score Over Time From Baseline to Week 24   [ Time Frame: Baseline, 24 weeks ]

3.  Secondary:   Pustule Count (if Present at Baseline) From Baseline to Week 24   [ Time Frame: Baseline, 24 weeks ]

4.  Secondary:   Fissure Count (if Present at Baseline) From Baseline to Week 24   [ Time Frame: Baseline, 24 weeks ]

5.  Secondary:   Pruritus Visual Analog Scale From Baseline to Week 24   [ Time Frame: Baseline, 24 weeks ]

6.  Secondary:   Pain Visual Analog Scale From Baseline to Week 24   [ Time Frame: Baseline, 24 weeks ]

7.  Secondary:   Safety Outcome Measures   [ Time Frame: 24 weeks ]


  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 NOT 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: Dr. Alice Gottlieb
Organization: Tufts Medical Center
phone: 617-636-7462
e-mail: Agottlieb@tuftsmedicalcenter.org


No publications provided


Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01090063     History of Changes
Other Study ID Numbers: Palmar Plantar Psoriasis
Study First Received: March 15, 2010
Results First Received: August 13, 2012
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board