Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis (NCT00301002) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis
Canada15 participantsStarted 2005-06
Plain-language summary
The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 inve…