Clinical trial NCT01611844: Optimization of Tuberculosis Intradermal Skin Test
Official title: Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: delayed-type hypersensitivity reaction to tuberculin intradermal injection
tuberculosis skin test
BD micro-needle
medical device
spectroscopy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 .


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

Primary outcomes:
measure: hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1]
timeFrame: 72 h
Secondary outcomes:
measure: spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction
timeFrame: 72 h
measure: 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
timeFrame: 48 h
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: 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
Study officials:
affiliation: Centre Hospitalier Lyon Sud -Hospices Civils de Lyon
name: Catherine GOUJON, MD
role: PRINCIPAL_INVESTIGATOR
References: