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New rapid test could speed up diagnosis of parasitic skin disease

NCT ID NCT01865032

Diagnosis Sponsor: U.S. Army Medical Research and Development Command Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study evaluated a new rapid test called CL Detect™ for diagnosing cutaneous leishmaniasis, a skin infection caused by parasites. Researchers tested 150 adults with skin ulcers to see how well the rapid test works compared to the standard method of looking at samples under a microscope. The goal was to find out if the rapid test can accurately identify the infection, which could lead to faster diagnosis and treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

150 people

The number who actually took part.

Started

Jun 2013

Finished

Apr 2014

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Dermatology clinic

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

cutaneous leishmaniasis leishmaniasis skin disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Skin diseases

Contacts and locations

Locations

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.