Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT01091051
Status:
TERMINATED
Last Update Posted:
2013-06-11
First Post:
2010-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
Sponsor:
Innovaderm Research Inc.
Organization:
Study Overview
Official Title:
Safety and Efficacy of Ustekinumab in the Treatment of Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Manufacturer ceased to produce vials used for this study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will provide data on sasety and efficacy of Ustekinumab in patients suffering from Palmo-Plantar Pustular Psoriasis (PPPP) or Palmo-Plantar Pustulosis(PPP)
Detailed Description:
Twenty patients with active Palmo-Plantar Pustular Psoriasis (cohort A) and twenty patients with active Palmo-Plantar Pustulosis (cohort B) will be included in this placebo-controlled double-blind study.Patients in each cohort will be randomized (1:1) to receive either ustekinumab S/C (Sub-Cutaneous) (45 mg for patients weighting 100 kg or less, and 90 mg for patients weighting more than 100 kg) or placebo.
Patients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20 whereas patients randomized to placebo (10 with PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20.
Patients will be seen at screening, Day 0, Weeks 4, 8, 16, 20, 24 and 28. The PPPASI (Palmo-Plantar Pustular Area and Severity Index), PPPGA (Palmo-Plantar Physician Global Assessment), PPSA (Palmo-Plantar Surface Area) will be used to evaluate severity and DLQI (Dermatology Life Quality Index), WPAI:PSO (Work Productivity and Activity Impairement Questionnaire:Psoriasis) and PPQoLI (Palmo-Plantar Quality of Life Index)will be used to evaluate quality of life. Safety will be assessed by physical examinations, evaluation of adverse events and laboratory analyses.
High quality digital medical photographs of palms and soles will be taken at Day 0, Weeks 4, 16 and 28. In addition, one optional skin biopsy from a palm or a sole will be performed at Day 0 and Week 16 and pus will be collected from pustules on palms and/or soles at Day 0 and Week 16. Finally, blood will be collected at Day 0 for genetic analysis from every patient who consents to DNA blood sampling.
Patients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20 whereas patients randomized to placebo (10 with PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20.
Patients will be seen at screening, Day 0, Weeks 4, 8, 16, 20, 24 and 28. The PPPASI (Palmo-Plantar Pustular Area and Severity Index), PPPGA (Palmo-Plantar Physician Global Assessment), PPSA (Palmo-Plantar Surface Area) will be used to evaluate severity and DLQI (Dermatology Life Quality Index), WPAI:PSO (Work Productivity and Activity Impairement Questionnaire:Psoriasis) and PPQoLI (Palmo-Plantar Quality of Life Index)will be used to evaluate quality of life. Safety will be assessed by physical examinations, evaluation of adverse events and laboratory analyses.
High quality digital medical photographs of palms and soles will be taken at Day 0, Weeks 4, 16 and 28. In addition, one optional skin biopsy from a palm or a sole will be performed at Day 0 and Week 16 and pus will be collected from pustules on palms and/or soles at Day 0 and Week 16. Finally, blood will be collected at Day 0 for genetic analysis from every patient who consents to DNA blood sampling.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: