Analysis of Lyme Disease Lesions
Completed
Conditions studied: Erythema Migrans Lesions, Erythema Migrans
In brief
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.
Key facts
- Study ID
- NCT00132327
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 27
- Starts
- 2005-08-17
- Expected to finish
- 2018-11-29
- Last updated by the study team
- 2018-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Patients:
- Antibiotic therapy for the current episode of Lyme disease
- Oral corticosteroids within the past 2 weeks
- History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year.
- Diagnosis of diabetes, active cancer, or autoimmune diseases.
- Investigational drugs in the past month
- History of forming large thick scars after skin injuries or surgery
- History of excessive bleeding after cuts or procedures or on anticoagulation.
- Use of steroid cream/ointment at the rash.
- Healthy Volunteers:
- History of Lyme disease, or serological evidence for Lyme disease
- No oral corticosteroids within the past 2 weeks
- History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year.
- Diagnosis of diabetes, cancer, autoimmune diseases.
- Investigational drugs in the past month
- History of forming large thick scars after skin injuries or surgery
- No history of excessive bleeding after cuts or procedures or on anticoagulation.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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