Plaque Psoriasis Clinical Trial
Official title:
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Mild Breakthrough in Moderate to Severe Plaque Psoriasis Patients Receiving Efalizumab ( Raptiva).
The purpose of this study is to determine if calcipotriene/bethamethasone can safely and
effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving
efalizumab (Raptiva) for moderate to severe plaque psoriasis.
It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB
and thus allow patients to continue efalizumab without interruption.
LMB (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in
efalizumab treated patients. It is generally papular in nature and does not involve existing
lesions. Clinical experience suggests that LMB may not have a clinical impact in patients
responding to efalizumab and therefore may be treated without interrupting efalizumab
therapy. To relieve discomfort topical therapy may be indicated until the symptoms are
resolved.
This is a single arm, open label study. Fifteen patients who are receiving efalizumab before
entrance into this study and who develop LMB wil be enrolled. Topical
calcipotriene/betamethasone (Taclonex) will be applied to the areas (except face, axillae or
groin) once a day for two weeks. The PI may choose to continue two more weeks if needed for
a total of four weeks of therapy. All patients will continue with efalizumab without dose
modification for the duration of the study. Patients will return for follow up visits at
weeks 2, 4 and 6. Topical desonide may be used for LMB involvement of the face, groin or
axillae.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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