Analysis of Lyme Disease Lesions
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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.
| Condition |
|---|
| Erythema Migrans Lesions Erythema Migrans |
| Study Type: | Observational |
| Official Title: | Analysis of Erythema Migrans Lesions |
| Estimated Enrollment: | 60 |
| Study Start Date: | August 16, 2005 |
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
- 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.
Contacts and Locations
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
| Contact: Adriana R Marques, M.D. | (301) 435-7244 | lymedxstudies@niaid.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Adriana R Marques, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00132327 History of Changes |
| Other Study ID Numbers: |
050219 05-I-0219 |
| First Submitted: | August 18, 2005 |
| First Posted: | August 19, 2005 |
| Last Update Posted: | October 6, 2017 |
| Last Verified: | July 11, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
|
Lyme Disease Borrelia Burgdorferi Inflammation Skin |
Host Response Erythema Migrans Rash Healthy Volunteer HV |
Additional relevant MeSH terms:
|
Glossitis, Benign Migratory Erythema Lyme Disease Erythema Chronicum Migrans Skin Diseases Borrelia Infections Gram-Negative Bacterial Infections Bacterial Infections Tick-Borne Diseases |
Spirochaetales Infections Skin Diseases, Bacterial Skin Diseases, Infectious Infection Glossitis Tongue Diseases Mouth Diseases Stomatognathic Diseases |