Analysis of Lyme Disease Lesions

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00132327
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Adriana R Marques, M.D.
Principal Investigator Affiliation	National Institute of Allergy and Infectious Diseases (NIAID)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Erythema Migrans Lesions, Erythema Migrans
Study Website:	View Trial Website

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

[email protected]

800-411-1222 #TTY8664111010

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