A Placebo-Controlled Double-Blind Study on the Safety and Efficacy of Etanercept in Palmoplantar Pustulosis
Condition: Palmoplantaris Pustulosis
MeSH terms: Psoriasis
Intervention: Placebo comparator; Etanercept
Intervention description: Patients received placebo subcutaneously twice weekly; Patients received etanercept 50 mg subcutaneously twice weekly
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Palmoplantar pustulosis; Psoriasis; Etanercept

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Palmoplantar pustulosis with a severity score of at least 8 on hands and-or feet

          -  Age 18 years or older

          -  Patient who would benefit from systemic therapy

          -  Unless surgically sterile (or at least 1 year post-menopausal for women) patients
             (heterosexual men and women) must have used a effective method of contraception for at
             least 30 days before the start of the study drug and until at least 1 month after the
             last drug administration

          -  Informed consent obtained

          -  Normal or non clinically significant chest X ray taken within 6 months of screening

          -  Negative serum pregnancy test at screening and negative urine pregnancy test at day 0
             for women of childbearing potential

          -  Negative personal history of tuberculosis

          -  Presence of PPP for more than 6 months

          -  Subject must be willing to inject themselves subcutaneously.

          -  Negative PPD results

        Exclusion Criteria:

          -  Use of topical steroids, topical tar preparations, or other topical anti PPP or
             anti-psoriatic preparations within the past two weeks

          -  Unstable forms of psoriasis (acute guttate psoriasis, psoriatic erythroderma,
             generalized pustular psoriasis)

          -  At the investigator's discretion any significant infection within 30 days of screening
             or a patient at risk of septicemia

          -  Presence of acute forms of tinea pedis and other causes of pustular eruptions of the
             palms and soles apart from PPP based on clinical evaluation

          -  Evidence of any skin condition that would interfere with the evaluation of PPP

          -  Use of investigational drugs within the past four weeks

          -  Use of systemic anti-PPP or anti-psoriatic drugs such as steroids, retinoids, or
             methotrexate within the past four weeks

          -  Use of parenteral systemic antibiotics within the past four weeks

          -  Use of cyclosporine within the past four weeks

          -  Use of ultraviolet light therapy (UVB, nbUVB or PUVA) within the past two weeks

          -  An unstable or serious medical condition

          -  Known sero-positivity for the HIV virus

          -  Known hypersensitivity to etanercept or one of its components

          -  Receipt of live attenuated vaccines 12 weeks or less before Day 0 and during the
             course of the study

          -  Pregnant or breast feeding female subject

          -  Any significant medical condition that might cause this study to be detrimental to the
             patient

          -  At the investigator's discretion current or history of alcohol or drug abuse that
             would interfere with the ability to comply with the study protocol

          -  Presence of congestive heart failure

          -  Presence of a demyelinating disorder (optic neuritis, multiple sclerosis or other)