Status:
COMPLETED
Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis
Lead Sponsor:
The Guenther Dermatology Research Centre
Collaborating Sponsors:
Biogen
Conditions:
Psoriasis
Palmoplantaris Pustulosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis.
Detailed Description
Palmar plantar pustulosis is a chronic, disabling skin condition which is difficult to treat since it is often recalcitrant to current treatments and associated with high recurrence rates. This condit...
Eligibility Criteria
Inclusion
- Subjects must have stable, moderate, severe or very severe palmar plantar pustulosis.
- Must have a minimum of at least 3 pustules on 1 sole or palm.
- Must give written informed consent.
- Subjects must be 18 years of age or older.
- Adult Males and non-pregnant, non-lactating females.
- Female subjects of childbearing potential must state that they are using measures to avoid conception through active means.
- Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of palmar plantar pustulosis or which would increase their health risk by study participation.
- Subjects must be willing to receive a 15 mg IM injection of Alefacept weekly for 16 weeks.
Exclusion
- Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy.
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
- Any subject whose CD4+ T-lymphocyte count at study entry is less than the lower limit of normal per reference laboratory.
- Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
- Treatment with psoralen + ultraviolet A (PUVA), systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
- Ultraviolet B (UVB) phototherapy within 14 days prior to investigational drug administration.
- Treatment within 7 days with topical agents (e.g. tar, anthralin, calcipotriol, tazarotene, steroids) which might have an effect on palmar plantar pustulosis.
- Known HIV, Hepatitis B or C seropositivity or tuberculosis infection.
- Significant abnormal chemistry, i.e. liver function tests greater than 3 times the upper limit of normal.
- Allergy to Alefacept or any of the components of the formulation.
- Known malignancy or history of malignancy within the previous 5 years (with the exception of basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence.)
- Previous treatment with alefacept.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00301002
Start Date
June 1 2005
End Date
October 1 2006
Last Update
November 23 2006
Active Locations (1)
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1
The Guenther Dermatology Research Centre
London, Ontario, Canada, N6A 3H7