Analysis of Lyme Disease Lesions
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/5/2018 |
| Start Date: | August 17, 2005 |
| End Date: | November 29, 2018 |
Analysis of Erythema Migrans Lesions
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.
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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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