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Thank
you for your interest the lichen planus study.
The purpose of this study is to perform a
pilot study to determine the preliminary efficacy and safety
of alefacept (amevive) in the treatment of moderate to severe
erosive mucosal lichen planus. You will be able to continue
using certain medications (topical steroids and emollients)
for lichen planus throughout the trial, and you will be
compensated $320 for your completion of the trial. Before starting the study, you will have a screening visit,
which will include a physical exam and a review of your
medical history, and a blood draw, to determine if you are
eligible to enroll in the study. All participants must be at
least 18 years of age with a clinical diagnosis of moderate to
severe erosive mucosal lichen planus. Neither pregnant nor
nursing women will be included in the study. If you are eligible, you will return every week for the first
12 weeks to receive the study drug; the next 12 weeks will be
a follow-up period. During visits at 0, 2, 4, 8, 12, 16 and 24
weeks, you will also fill out questionnaires and have blood
drawn for additional tests. You will be randomly assigned (by
chance) to receive either alefacept or placebo through an
intramuscular injection (in the muscle) once a week by a study
physician. You have an equal chance of receiving alefacept or
placebo. The entire study will be “blinded”, meaning that
neither you nor the evaluating physician will know whether you
are receiving the drug or the placebo. You have the option to
withdraw from the study at any time. Please contact us by e-mail or phone with any questions you
may have and to schedule a screening appointment, if
interested. Dermatology Joint Clinical Trials Unit
Massachusetts General Hospital (617-726-1660)
Brigham and Women’s Hospital (617-525-7975)
harvardskinstudies@partners.org
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