Optimization of Tuberculosis Intradermal Skin Test

NCT ID: NCT01611844

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Medical device : micro-needle BD 1.5 mm 30G

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine GOUJON, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud -Hospices Civils de Lyon

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, , France

Countries

France

References

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)

Reference Type: BACKGROUND

Other Identifiers

2009.591

Identifier Type: -

Identifier Source: org_study_id