Analysis of Lyme Disease Lesions

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00132327
First received: August 18, 2005
Last updated: March 14, 2014
Last verified: December 2013
  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, 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: Microarray Analysis of Erythema Migrans Lesions

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 40
Study Start Date: August 2005
Detailed Description:

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 DNA microarrays to characterize gene expression patterns in skin biopsies from individuals with a diagnosis of EM and compared those to the patterns of gene expression seen in biopsies from normal, unaffected individuals. Biopsies from patients may also be evaluated for B. burgdorferi gene expression using microarrays. Patients diagnosed with erythema migrans will have 4 4-mm 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132327

Contacts
Contact: Adriana R Marques, M.D. (301) 435-7244 amarques@niaid.nih.gov

Locations
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   
Sponsors and Collaborators
Investigators
Principal Investigator: Adriana R Marques, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00132327     History of Changes
Other Study ID Numbers: 050219, 05-I-0219
Study First Received: August 18, 2005
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Lyme Disease
Borrelia Burgdorferi
Inflammation
Skin
Host Response
Erythema Migrans Rash
Healthy Volunteer
HV

Additional relevant MeSH terms:
Tick-Borne Diseases
Erythema
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Diseases
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 18, 2014