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Could a tiny needle make TB testing easier and more accurate?

NCT ID NCT01611844

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new micro-needle for giving TB skin tests, comparing it to the standard method in 59 healthy volunteers. The goal was to see if the new needle makes the test easier to give and more consistent. Researchers also tested a device to read the skin reaction without measuring by hand.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tuberculin (purified protein derivative)
What this could lead to
If successful, this could make TB skin testing easier and more reliable, allowing any healthcare worker to administer it.
What could go wrong
This is a small, early-phase study in healthy volunteers, so results may not apply to all populations or settings. The new method may not prove better than the current one.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

59 people

The number who actually took part.

Start date

Sep 2011

Finished

Apr 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Subject aged 18 years or over * Tuberculosis skin test (PPD) * positive : 5mm =\<PPD\<15mm (24 subjects) * negative: PPD \< 5mm (6 subjects) * Negative Quantiferon test. * Legal capacity to consent * Subject had given written consent before his participation * Subject accepting to participate in the second phase of the study with skin biopsies (24 subjects with positive PPD) * Females of childbearing potential using an effective method of contraception, for at least 1 month before the beginning of the study and until 1 month after the end of their participation Exclusion Criteria: * Known allergy to tuberculin * History of severe skin reaction to tuberculin with vesicle, ulceration, necrosis * History of active tuberculosis * Latent tuberculosis (positive Quantiferon test) * Contact with a person having or having had active tuberculosis in the previous 3 months * Chronic disease non-stabilized under treatment * Immunosuppressive therapy or corticosteroids within 1 month before PPD skin tests * Non-steroid anti-inflammatory drugs within 1 week before PPD skin tests * Application on study areas of topical drugs containing corticoids or immunosuppressants within 1 week before PPD skin test * Dermatological disease on study area * Known allergy to local anesthetics * Wound healing disorders * Subject in an exclusion period or participating or planning to participate in another biomedical research

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As listed by the trial registrant

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

Healthy volunteers

Contacts and locations

Locations

  • Unité de Recherche Clinique en Immunologie Lyon Sud (URCI-LS) et Service d'Immunologie clinique et allergologie-Centre Hospitalier Lyon Sud -Hospices Civils de Lyon

    Pierre-Bénite, 69495, France

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