Erythema Migrans Clinical Trial
Official title:
Analysis of Erythema Migrans Lesions
Verified date | November 29, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | November 29, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Casjens S, Palmer N, van Vugt R, Huang WM, Stevenson B, Rosa P, Lathigra R, Sutton G, Peterson J, Dodson RJ, Haft D, Hickey E, Gwinn M, White O, Fraser CM. A bacterial genome in flux: the twelve linear and nine circular extrachromosomal DNAs in an infectious isolate of the Lyme disease spirochete Borrelia burgdorferi. Mol Microbiol. 2000 Feb;35(3):490-516. — View Citation
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. — View Citation
Fraser CM, Casjens S, Huang WM, Sutton GG, Clayton R, Lathigra R, White O, Ketchum KA, Dodson R, Hickey EK, Gwinn M, Dougherty B, Tomb JF, Fleischmann RD, Richardson D, Peterson J, Kerlavage AR, Quackenbush J, Salzberg S, Hanson M, van Vugt R, Palmer N, Adams MD, Gocayne J, Weidman J, Utterback T, Watthey L, McDonald L, Artiach P, Bowman C, Garland S, Fuji C, Cotton MD, Horst K, Roberts K, Hatch B, Smith HO, Venter JC. Genomic sequence of a Lyme disease spirochaete, Borrelia burgdorferi. Nature. 1997 Dec 11;390(6660):580-6. — View Citation
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