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Status:

COMPLETED

Analysis of Lyme Disease Lesions

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Erythema Migrans Lesions

Erythema Migrans

Eligibility:

All Genders

18+ years

Brief Summary

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 ba...

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 a variety of techniq...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 17 2005

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 29 2018

    Estimated Enrollment :

    27 Patients enrolled

    Trial Details

    Trial ID

    NCT00132327

    Start Date

    August 17 2005

    End Date

    November 29 2018

    Last Update

    December 3 2018

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892