Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis

Completed

Conditions studied: Skin Diseases

In brief

This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amastigotes in a stained lesion sample.

Key facts

Study ID

NCT01865032

Run by

U.S. Army Medical Research and Development Command

People needed

150

Starts

2013-06-01

Expected to finish

2014-04-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Subject is able to give written informed consent
• Subject has a skin ulcer that satisfies the following criteria for an index lesion:
• less than 4 months in age
• primarily ulcerative, not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
• in a location suitable for collecting samples by dental broach and scraping
• In the opinion of the investigator, the subject is capable of understanding and complying with the protocol

You may not qualify if…

• Received treatment for leishmaniasis or any treatment to the lesion even if not previously diagnosed as leishmaniasis such as azoles, cryotherapy, imiquimod, thermotherapy, photodynamic therapy, within 2 months prior to signing the consent form, with the exception of mercurochrome

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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