Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis

Conditions

• Palmo-Plantar Pustular Psoriasis
• Palmo-Plantar Pustulosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ustekinumab — DRUG
  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
• Placebo (Soduim Chloride) — DRUG
  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

Study Details

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)

Key Dates

Start date

Mar 31, 2010

Status verified

Jun 2013

Primary completion

Aug 31, 2011

Completion

Nov 30, 2011

Study Design

Enrollment

33 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Ustekinumab
  Ustekinumab S/C 45mg or 90mg depending on patient's weight or placebo injection. 10 with PPPP and 10 with PPP will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20
• Placebo Comparator: Placebo
  Placebo S/C (Sodium Chloride). 10 with PPPP and 10 with PPP will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20

Primary Outcome Measure

Proportion of patients with PPPP who reach PPPASI-50 at Week 16 for patients randomized to ustekinumab as compared to patients randomized to placebo [ Time Frame: 16 week ]