Microneedles for Diagnosis of LTBI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2022-10-01

Brief Summary

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This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers

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Detailed Description

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The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.

Conditions

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Latent Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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volunteers

two different types of diagnostic tools (TST vs microneedle) will be used to screen for latent TB infection

Group Type OTHER

TST vs PPD microneedle test

Intervention Type DIAGNOSTIC_TEST

TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation

Interventions

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TST vs PPD microneedle test

TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Sex : Male and Female
2. Age : 20-60 years
3. TB contacts or those at risk of TB e.g. health-care workers
4. HIV-negative healthy individuals

Exclusion Criteria

1. Presence of an acute infection, as determined by investigators
2. Receiving immunosuppression drugs e.g. steroids
3. Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)
4. Being pregnant or breastfeeding

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes