NCT00132327

Analysis of Lyme Disease Lesions

Completed Last updated 3 December 2018

What this trial tests

trial in Erythema Migrans Lesions in 27 participants. Completed in 29 November 2018.

Timeline

17 August 2005

29 November 2018

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	27
Start date	17 August 2005
Estimated completion	29 November 2018
Sites	1 location across United States

Conditions studied

• Erythema Migrans Lesions — all drugs for Erythema Migrans Lesions →
• Erythema Migrans — all drugs for Erythema Migrans →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

18 and older, any sex, with Erythema Migrans Lesions or Erythema Migrans. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcriptome Assessment of Erythema Migrans Skin Lesions in Patients With Early Lyme Disease Reveals Predominant Interferon Signaling.
   Marques A, Schwartz I, Wormser GP, Wang Y, et al · · 2017 · cited 38× · PMID 29099929 · DOI 10.1093/infdis/jix563
2. Antimicrobial action of calprotectin that does not involve metal withholding.
   Besold AN, Culbertson EM, Nam L, Hobbs RP, et al · · 2018 · cited 25× · PMID 30206620 · DOI 10.1039/c8mt00133b