Clinical trial: Analysis of Lyme Disease Lesions (NCT00132327)

Eligibility 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 31-year-old woman comes to the office due to 3 days of rash on her left arm.  The lesion is mildly pruritic but not painful.  She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period.  Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease.

Patient description (patient's own words): I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease.

Does the patient match the trial criteria? Contradiction