Clinical Trial: Study to Evaluate the Efficacy of Alefacept to Treat Palmar Plantar Pustulosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Open-Label Study to Evaluate the Safety and Observe the Effectiveness of 16 Weeks of Alefacept in Palmar Plantar Pustulosis (IST 92)
Brief Summary: The purpose of this study is to determine if Alefacept is effective in the treatment of palmar plantar pustulosis.
Detailed Summary: 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 condition appears to be a T lymphocyte mediated condition and is thought by some to be a subtype of psoriasis. Alefacept affects T cell activation and induces apoptosis of memory T cells. It has been shown to be efficacious in the treatment of psoriasis vulgaris and may be associated with prolonged remissions. There is extremely limited experience with use of Alefacept in Palmar Plantar Pustulosis. This pilot trial should provide additional information concerning its use for this indication.
Sponsor: The Guenther Dermatology Research Centre
Current Primary Outcome: percentage change in PPPASI from baseline
Original Primary Outcome: Same as current
Current Secondary Outcome:
- number of subjects with PPPASI 75
- number of subjects with PPPASI 50
- number of subjects with very mild/clear PGA
- number of subjects with no pustules
Original Secondary Outcome: Same as current
Information By: The Guenther Dermatology Research Centre
Dates:
Date Received: March 8, 2006
Date Started: June 2005
Date Completion: October 2006
Last Updated: November 21, 2006
Last Verified: November 2006
