Status:
COMPLETED
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
Lead Sponsor:
Nielsen BioSciences, Inc.
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of Lt...
Eligibility Criteria
Inclusion
- Male or Female in good health;
- Age 18 - 60 years;
- No past history of leishmaniasis or prior participation in a Leishmania study;
- No prior skin test with a Leishmania antigen;
- No occupational, residential, or travel exposure to Leishmania;
- Positive Candin® or Trichophyton skin test (\>= 5 mm induration).
Exclusion
- History of adult atopic dermatitis, contact dermatitis to multiple agents, unexplained urticaria, or asthma;
- Active allergic rhinitis or conjunctivitis;
- History of allergy or reactions to phenol, polysorbate 80, or glycerol;
- Medications: currently taking (within the last month) antihistamines or recent history of taking (within the last 1 year) corticosteroids, immunosuppressants;
- Splenectomy;
- Active medical disease\*;
- \*Active Medical Disease: Any active physical or psychiatric condition that may increase the risks associated with participation in the study or interferes with the interpretation of study results. Included chronic medical illnesses are cardiovascular disease, renal insufficiency, chronic respiratory illness, cirrhosis, chronic hepatitis, chronic pancreatitis, chronic diarrhea, malnutrition, malignancy, autoimmune disease, and asthma.
- Pregnancy or lactating;
- Immunization within 4 weeks;
- History of leishmaniasis;
- Occupational exposure to Leishmania;
- Prior participation in a Leishmania study;
- Prior skin test with Leishmania antigen;
- Travel history to Leishmania endemic areas;
- Abnormal screening lab results;
- Keloid scar formation
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00633009
Start Date
August 1 2008
End Date
January 1 2010
Last Update
November 20 2013
Active Locations (1)
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1
California Research Foundation
San Diego, California, United States, 92103-6204