Leprosy Skin Test Antigens Trial

Completed · Phase 2 · Has a placebo group

Conditions studied: Leprosy

In brief

The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage. Participant's ages 18-60 living in Kathmandu, Nepal will be enrolled. Stages A and B of the study will use the skin test in healthy volunteers. Stage C will use the skin test in high risk volunteers (including individuals with leprosy), healthy individuals in contact with leprosy patients and individuals with tuberculosis (TB, lung disease). Study procedures will include injections, physical exam, and blood testing. Injection sites will be checked several times during the participant's study involvement (5 hours of time spread over approximately 1 month). Volunteers screened for the study, which have leprosy or tuberculosis will be treated or referred for treatment.

Key facts

Study ID

NCT00128193

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

260

Starts

2002-04-01

Expected to finish

2009-09-01

Last updated by the study team

2014-12-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All Subjects
• Between the ages of 18 and 60 years old
• Male or female; not less than 30 percent for one gender
• Agree to participate in the study after verbal explanation by the physician and nurses, as indicated by signing an informed consent form
• Weight greater than 30 Kg (female) and 38 Kg (male)
• Available for skin test readings
• Nepali residents, including expatriates from India
• Healthy, Non-Contacts
• Healthy (determined by history and physical examination)
• No household or working contact with tuberculosis or leprosy patients
• Contacts of Leprosy Patients
• Healthy (determined by history and physical examination)
• Household contact of a person with leprosy for at least 6 months duration, and within 6 months of this study, or a person professionally exposed to leprosy for at least 5 years duration, and within 6 months of this study
• Persons with Leprosy
• Having one or more of the following symptoms:
• Hypopigmented or erythematous skin lesion(s) with definite loss of sensation
• Damage to the peripheral nerves as demonstrated by palpable thickening with or without impairment of sensation and/or weakness of the muscles of hands, feet or face
• Presence of acid-fast bacilli in slit skin smears
• Histological changes diagnostic of leprosy in skin biopsy
• Receiving standard multi drug treatment for leprosy or completed treatment for leprosy no more than 4 years prior to study enrollment
• Persons with Tuberculosis
• Having active tuberculosis as defined by one of the following:
• Extra-pulmonary tuberculosis if confirmed by culture
• Pulmonary tuberculosis, defined as:
• Having a history of a productive cough of more than 3 weeks duration that may be accompanied by night sweats, loss of appetite, haemoptysis, weight loss, chest pain, or shortness of breath, and

You may not qualify if…

• All subjects
• Pregnant (as determined by a urine pregnancy test performed on females of child-bearing age on Day 0, prior to admission into the study) or lactating females
• Currently on oral corticosteroid or other immunosuppressive treatment
• Cancer, diabetes, or other chronic illness
• Extra-pulmonary tuberculosis not confirmed by culture
• Known hypersensitivities or allergies
• Expatriates other than those from India
• Participation in an earlier stage of this study
• Concurrent participation in another clinical trial
• Healthy, Non-Contacts
• History of treated tuberculosis or leprosy
• Clinical signs of leprosy or tuberculosis
• Known contact with persons with leprosy or tuberculosis
• Healthy Contacts of Leprosy Patients
• History of treated tuberculosis or leprosy
• Clinical signs of leprosy or tuberculosis
• Persons with Leprosy
• Leprosy patients in reversal reaction or erythema nodosum leprosum (ENL) reaction or those being treated with corticosteroids or thalidomide for these conditions
• History of treated tuberculosis
• Clinical signs of tuberculosis
• Completed full course of standard multidrug treatment (MDT) for leprosy more than 4 years prior to study enrollment
• Persons with Tuberculosis
• History of treated leprosy
• Clinical signs of leprosy
• Completed full course of standard tuberculosis treatment

Where it is running

• Colorado State University - Microbiology, Immunology & Pathology — Fort Collins, Colorado, United States
• Anandaban Hospital — Kathmandu, Nepal
• Green Pastures Hospitals — Kathmandu, Nepal
• Lalitpur Nursing Campus — Kathmandu, Nepal
• Patan Hospital — Kathmandu, Nepal
• Tribhuvan University - Anandaban Hospital — Kathmandu, Nepal

Full record on ClinicalTrials.gov

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