Erythema Migrans Lesions | Analysis of Lyme Disease Lesions
Erythema Migrans Lesions research study
What is the primary objective of this study?
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.
Who is eligible to participate?
- INCLUSION CRITERIA: Patients: Age greater than or equal to 18 years Diagnosis of EM - an expanding annular lesion, at least 5 cm in diameter on a person with a history of exposure to the disease. Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) in an area in which Lyme disease is endemic. A history of tick bite is not required. The area of the erythema migrans lesion is suitable for biopsy. This excludes biopsies on the face, neck, scalp, and over the tibia. Not know to be positive for RPR, HIV, HBsAg or HCV Able to give consent Healthy Volunteers: Age greater than or equal to 18 years Not positive for RPR, HIV, HBsAg or HCV. Able to give consent EXCLUSION CRITERIA: 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Erythema Migrans Lesions
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: August 17, 2005
Completed Date: November 29, 2018
Study sponsors, principal investigator, and references
Principal Investigator: Adriana R Marques, M.D.
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Centers for Disease Control and Prevention (CDC). Lyme disease--United States, 2001-2002. MMWR Morb Mortal Wkly Rep. 2004 May 7;53(17):365-9.