Analysis of Lyme Disease Lesions
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|ClinicalTrials.gov Identifier: NCT00132327|
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : December 3, 2018
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.
|Condition or disease|
|Erythema Migrans Lesions Erythema Migrans|
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Official Title:||Analysis of Erythema Migrans Lesions|
|Study Start Date :||August 17, 2005|
|Study Completion Date :||November 29, 2018|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132327
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Adriana R Marques, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|