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Completed

NCT Number: NCT01611844

Optimization of Tuberculosis Intradermal Skin Test

The only test available for in vivo diagnosis of tuberculosis is the intradermal injection of tuberculin according to the Mantoux method (also named tuberculosis skin test or PPD skin test).

The tuberculin skin test is based on a delayed-type hypersensitivity skin reaction However, this test needs to be performed by trained personnel, presents problem of reproducibility, and its interpretation is not well standardized (measure in millimeters of skin induration 48 to 72 hours after the PPD skin test).

The new generation BD micro needle used in this study should solve the technical difficulties; intradermal administration of tuberculin could then be made by any personnel.

A non-invasive and objective instrumental method of reading the test will be also tested .

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative)

Device

2 intradermal injections are performed on each arm/bottom of the subject:

  • 1 intradermal injection of Tuberculin (5UI)
  • 1 intradermal injection of saline solution using Manthoux method or BD micro-needle. the method of injection is randomized: left or right

medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)

Device

2 intradermal injections are performed on each arm/bottom of the subject:

  • 1 intradermal injection of Tuberculin (5UI)
  • 1 intradermal injection of saline solution using Manthoux method or BD micro-needle. the method of injection is randomized: left or right

Primary outcomes

  1. hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1]

    Time frame: 72 h

Secondary outcomes

  1. spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction

    Time frame: 72 h

  2. define changes in the cutaneous immune system at various times (7h, 24h and 48 h), induced by intradermal microinjection of tuberculin, by histological, immunohistochemical and molecular analysis

    Time frame: 48 h

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1

Acronym: TB Dermatest

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 5, 2012
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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