Optimization of Tuberculosis Intradermal Skin Test (TB Dermatest)

Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1

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 .

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative); Device: medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medical device : micro-needle BD 1.5 mm 30G	Device: Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative); 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
Active Comparator: Manthoux method: lance 26G X 16mm	Device: medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1]	72 h

Secondary Outcome Measures

Outcome Measure	Time Frame
spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction	72 h
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	48 h

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Catherine GOUJON, MD, Centre Hospitalier Lyon Sud -Hospices Civils de Lyon

Publications and helpful links

General Publications

• Diffuse Reflectance Spectroscopy: A clinical study of tuberculin skin tests reading Anne Koenig, Sophie Grande, Karima Dahel, Anne Planat-Chrétien, Vincent Poher, Catherine Goujon, Jean- Marc Dinten. Biomedical Applications of Light Scattering VII, 85920S (21 February 2013)

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimated): June 5, 2012

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: medical device; spectroscopy; delayed-type hypersensitivity reaction to tuberculin intradermal injection; tuberculosis skin test; BD micro-needle
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Immunologic Techniques; Immunologic Tests; Skin Tests; Tuberculin Test
• Other Study ID Numbers: 2009.591