Optimization of Tuberculosis Intradermal Skin Test

NCT01611844 | Completed

• 1 other identifier: 2009.591
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Healthy Volunteers

Keywords

delayed-type hypersensitivity reaction to tuberculin intradermal injection; tuberculosis skin test; BD micro-needle; medical device; spectroscopy

Outcome Measures

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]

  72 h

Secondary Outcomes (2)

• 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

Study Arms (2)

Medical device : micro-needle BD 1.5 mm 30G

EXPERIMENTAL

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

Manthoux method: lance 26G X 16mm

ACTIVE COMPARATOR

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

Interventions

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 : micro-needle BD 1.5 mm 30G

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

Manthoux method: lance 26G X 16mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Location

Related Publications (1)

• 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)

  BACKGROUND

MeSH Terms

Interventions

Tuberculin Test

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Catherine GOUJON, MD

  Centre Hospitalier Lyon Sud -Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: June 5, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2013
• Last Updated: September 3, 2025

Record last verified: 2013-07

Locations

FR (1)