Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis (PPP)
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|ClinicalTrials.gov Identifier: NCT01090063|
Recruitment Status : Completed
First Posted : March 19, 2010
Results First Posted : March 11, 2013
Last Update Posted : October 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Moderate to Severe Palmar Plantar Psoriasis||Drug: Ustekinumab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigator-Initiated, Open-label Study Evaluating the Efficacy and Safety of Ustekinumab in Patients With Moderate to Severe Palmar Plantar Psoriasis|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||April 2012|
- Drug: Ustekinumab
Dosing will consist of a 45mg subcutaneous injection for patients weighing less than 100 kg and a 90 mg subcutaneous injection for patients whose weight is greater than 100 kg. Dosing will begin on week 0 followed by subsequent dosing on week 4 and week 16.Other Name: Stelara
- Percentage of Patients Achieving a Palmar/Plantar PGA Score of 0 or 1 at Week 16. [ Time Frame: 16 weeks ]
- PGA Score Over Time From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]Measurement of subject's palmar and plantar psoriasis severity as measured by the Physician's Global Assessment (PGA) scale, which rates the severity of psoriasis using the measures of erythema, scaling and induration. Scores are from 0 to 4, in 1 unit increments. A score of 4 is very severe, and a score of 0 is clear.
- Pustule Count (if Present at Baseline) From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]Number of pustules present in each subject
- Fissure Count (if Present at Baseline) From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]Number of discrete fissures on the hands and feet of each subject.
- Pruritus Visual Analog Scale From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]Patient's score on the questionnaire of "how itchy are you", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
- Pain Visual Analog Scale From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]Patient's score on the questionnaire of "how much pain are you experiencing from your disease of your hands and feet", as measured in mm from the left end of scale. Maximum score is 100, minimum score is 0. Visual Analog Scale (VAS). 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
- Safety Outcome Measures [ Time Frame: 24 weeks ]All adverse events (AE's) will be recorded and monitored. At each of the study visits, patients will be questioned about the occurrence of new AE's since the last visit, or the outcome of any AE's that were reported at previous visits. Upon study completion of the first 10 subjects the principal investigator will review all adverse events to check for trends.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090063
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Alice B Gottlieb, MD, PhD||Tufts Medical Center|