Clinical Trial: A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase 3 Study With a Placebo-Controlled, Double-blind, on the Safety and Efficacy of Etanercept in Palmo-Plantar Pustulosis

Brief Summary: Palmoplantar pustulosis (PPP) is a chronic recurrent skin condition characterized by the presence of pustules, erythema and hyperkeratosis on palms and soles. PPP can be a severe and disabling disease limiting the ability to walk or work. Although studies on the quality of life of patients with PPP are not available, a recent investigation showed that palmoplantar psoriasis (non pustular) has a more important impact on quality of life than plaque psoriasis. This important impact on quality of life is not surprising as palmoplantar psoriasis as well as palmoplantar pustulosis may limit the ability to work or conduct activities with hands or even impair walking. The disease is sometimes associated with psoriasis elsewhere on the body. Current treatments for PPP include topical corticosteroids, cyclosporine, PUVA therapy, methotrexate and acitretin. Response to topical corticosteroids and PUVA therapy is often disappointing presumably because the thickness of the stratum corneum on palms and soles prevents good penetration of topical medications and light. Cyclosporine and methotrexate are sometimes used with success for PPP but there are concerns with long term toxicity of both drugs. Therefore there is a need for new treatments for PPP.

Detailed Summary:

This is a placebo-controlled double blind study. Patients will be randomized to receive etanercept versus placebo in a 2:1 fashion for the first 3 months. All patients will receive etanercept in the last 3 months.

Patients with active PPP will be included. A washout of 4 weeks for systemic medications and 2 weeks for Psoralen Ultra Violet A (PUVA) therapy will be required. A washout period of 2 weeks will be required for all other topical medications. The Palmoplantar pustulosis severity index (PPPASI) will be used to evaluate severity. Only patients with a severity score of 8 or more on hands and/or feet will be included. Safety will be assessed by performing physical examinations, evaluation of adverse events and biological parameters (complete blood count (CBC), chemistry, urinalysis).

High quality digital medical photographs will be taken at baseline, 3 months and 6 months.

Current Primary Outcome: Percentage Change in Palmoplantar Pustulosis Severity Index (PPPASI) Before Crossover [ Time Frame: 12 weeks ]

Original Primary Outcome: Comparison of the percentage change in Palmoplantar pustulosis severity index PPPASI) at 3 months in patients treated with placebo and etanercept

Current Secondary Outcome:

• Number of Adverse Events [ Time Frame: 28 weeks ]
  Study the safety of etanercept in patients with PPP by collecting adverse events from the screening visit until week 28. For a given AE, a subject will be counted once even if he or she has experienced multiple episodes for that particular AE. An adverse event is any untoward medical occurrence including any clinically significant abnormal laboratory values or variation from the baseline condition to the last visit (week 28) in a patient receiving a pharmaceutical product, without regards to the possibility of a causal relationship with this treatment.
• Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) [ Time Frame: 24 weeks ]

  Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months

  PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).

  Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

• Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPPASI) After Crossover [ Time Frame: 12 weeks ]

  Evaluate efficacy using palmoplantar pustulosis area and severity index (PPPASI) in patient with palmoplantar pustulosis treated with etanercept for 6 months

  PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).

  Erythema, pustules and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

Original Secondary Outcome:

• Study the safety of etanercept in patients with PPP
• Evaluate efficacy using PPPASI in patient with PPP treated with etanercept for 6 months

Dates:
Date Received: July 14, 2006
Date Started: April 2006
Date Completion:
Last Updated: September 1, 2011
Last Verified: September 2011