Analysis of Lyme Disease Lesions

NCT00132327 | Completed

• 2 other identifiers: 05021905-I-0219
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Erythema Migrans Lesions; Erythema Migrans

Keywords

Lyme Disease; Borrelia Burgdorferi; Inflammation; Skin; Host Response; Erythema Migrans Rash; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Centers for Disease Control and Prevention (CDC). Lyme disease--United States, 2001-2002. MMWR Morb Mortal Wkly Rep. 2004 May 7;53(17):365-9.

  PMID: 15129194 BACKGROUND

• Fraser CM, Casjens S, Huang WM, Sutton GG, Clayton R, Lathigra R, White O, Ketchum KA, Dodson R, Hickey EK, Gwinn M, Dougherty B, Tomb JF, Fleischmann RD, Richardson D, Peterson J, Kerlavage AR, Quackenbush J, Salzberg S, Hanson M, van Vugt R, Palmer N, Adams MD, Gocayne J, Weidman J, Utterback T, Watthey L, McDonald L, Artiach P, Bowman C, Garland S, Fuji C, Cotton MD, Horst K, Roberts K, Hatch B, Smith HO, Venter JC. Genomic sequence of a Lyme disease spirochaete, Borrelia burgdorferi. Nature. 1997 Dec 11;390(6660):580-6. doi: 10.1038/37551.

  PMID: 9403685 BACKGROUND

• Casjens S, Palmer N, van Vugt R, Huang WM, Stevenson B, Rosa P, Lathigra R, Sutton G, Peterson J, Dodson RJ, Haft D, Hickey E, Gwinn M, White O, Fraser CM. A bacterial genome in flux: the twelve linear and nine circular extrachromosomal DNAs in an infectious isolate of the Lyme disease spirochete Borrelia burgdorferi. Mol Microbiol. 2000 Feb;35(3):490-516. doi: 10.1046/j.1365-2958.2000.01698.x.

  PMID: 10672174 BACKGROUND

MeSH Terms

Conditions

Glossitis, Benign Migratory; Lyme Disease; Inflammation

Condition Hierarchy (Ancestors)

Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adriana R Marques, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 19, 2005
• Study Start: August 17, 2005
• Study Completion: November 29, 2018
• Last Updated: December 3, 2018

Record last verified: 2018-11-29

Locations

US (1)