Healthy VolunteersTB DermatestNCT01611844
Optimization of Tuberculosis Intradermal Skin Test
A study testing Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative) and medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative) in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative) and medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
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
About this study
Official title: 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).
Read more
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
- Being tested
- Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative), medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)
- Keywords
- delayed-type hypersensitivity reaction to tuberculin intradermal injection, tuberculosis skin test, BD micro-needle, medical device, spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Medical device : micro-needle BD 1.5 mm 30G | Experimental | Not described Receives: Device: Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative) |
| Manthoux method: lance 26G X 16mm | Active comparator | Not described Receives: Device: medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypersensitivity reaction to tuberculin measured in millimeters of skin induration by comparing two methods of intradermal injection (Mantoux and BD micro-needle). [Phase 1]
Measured: 72 h
Secondary outcomes (2)
spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction
Measured: 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
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GOUJON, MD, Principal investigator, Centre Hospitalier Lyon Sud -Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611844
- Sponsor's protocol ID
- 2009.591
- Acronym
- TB Dermatest
- Status last verified
- Jul 2013
- First submitted
- 22 Dec 2011
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Tuberculosis Intradermal Skin Test: TB Dermatest WP 3.1
- ClinicalTrials.gov ID
- NCT01611844
- Acronym / sponsor ID
- TB Dermatest / 2009.591
- Conditions
- Healthy Volunteers
- Keywords
- delayed-type hypersensitivity reaction to tuberculin intradermal injection, tuberculosis skin test, BD micro-needle, medical device, spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject aged 18 years or over
- Tuberculosis skin test (PPD)
- positive : 5mm =<PPD<15mm (24 subjects)
- negative: PPD < 5mm (6 subjects)
- Negative Quantiferon test.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Medical device : micro-needle BD 1.5 mm 30G |
| 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 | Device | Manthoux method: lance 26G X 16mm |
Primary outcome
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
2 secondary outcomes
spectroscopy instrumentation(non-invasive and objective method)to measure the PPD reaction
Time frame: 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
Time frame: 48 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publicationDiffuse 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)
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Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine GOUJON, MD principal investigator
Centre Hospitalier Lyon Sud -Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative) and medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative) in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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] (time frame: 72 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.