Erythema Migrans Clinical Trial
Official title:
Analysis of Erythema Migrans Lesions
This study will analyze cells from erythema migrans lesions, the "bull's eye" rash of Lyme
disease. Little is known about what happens in the skin when it is infected with Borrelia
burgdorferi, the bacteria that cause Lyme disease. This study will examine and compare
laboratory findings in skin biopsies from people with Lyme disease and from healthy normal
volunteers to try to better understand the infection.
Healthy volunteers and people with untreated erythema migrans rash who are 18 years of age or
older may be eligible for this study.
All participants undergo a clinical examination, blood tests, between two to four skin
biopsies (removal of a small piece of tissue for laboratory examination), and complete two
health questionnaires. The biopsies are taken from the erythema migrans lesion in patients
with Lyme disease and from skin on the legs, forearms, buttocks, or side from healthy
volunteers. To collect the tissue, the skin at the biopsy site is numbed with injection of a
local anesthetic and a sharp instrument is then used to remove a round plug of skin about the
size of a pencil eraser. The wound may be closed with one or two sutures, or allowed to heal
without sutures. The sutures are removed after a week to 10 days.
Patients with Lyme disease receive treatment for their condition. In addition, at the time
the sutures are removed and at 4 weeks, 6 months, and 12 months after their first visit they
fill out a questionnaire and have additional blood tests.
Little is known of the host and the bacteria response in vivo in patients with Lyme disease. In an attempt to better understand the pathology of erythema migrans (EM), we will use a variety of techniques to characterize patterns in skin biopsies from individuals with a diagnosis of EM and compared those to the patterns seen in biopsies from unaffected individuals. Biopsies from patients may also be evaluated for B. burgdorferi. Patients diagnosed with erythema migrans will have between 2 and 4 punch skin biopsies of affected area, and will return for 4 follow up visits in the course of a year. Therapy for Lyme disease will be offered. Healthy volunteers will have a screening visit, a visit for the skin biopsies and a follow up visit. Patients and healthy volunteers will be compensated for their time and inconvenience. ;
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