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

History of Changes

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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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

Safety Outcome Measures [ Time Frame: 24 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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.

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.

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

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