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A study to evaluate the utility of CyTb test in diagnosing skin tuberculosis

A pilot study to evaluate the utility of CyTb intradermal skin test in the diagnosis of cutaneous tuberculosis - Nil

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/105035
Enrollment
40
Registered
2026-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L00-L08- Infections of the skin and subcutaneous tissue Health Condition 2: L80-L99- Other disorders of the skin and subcutaneous tissue Health Condition 3: L08- Other local infections of skin andsubcutaneous tissue

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Dr Deepika Yadav
Lead Sponsor
Dr Ananya Sharma
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All patients more than 1 year of age with a clinical differential diagnosis including cutaneous tuberculosis or tuberculid, made by two independent dermatologists

Exclusion criteria

Exclusion criteria: Patients with diagnostic dilemma that cannot be resolved on the basis of special stains, culture, CB- 14 NAAT for Mycobacterium tuberculosis or therapeutic trial for 6 weeks, will be excluded from analysis 2. Patients who have evidence of active tuberculosis of a site other than skin on the basis of clinical features, microbiological and radiological evaluation done as per standard of care (i.e. Chest X-ray or Ultrasound abdomen/pelvis) 3. Persons with a history of severe reaction (necrosis, blistering, anaphylactic shock or ulceration) to a previous TB skin test 4. Patients on anti-tubercular therapy for more than 2 weeks 5. Pregnant patients

Design outcomes

Primary

MeasureTime frame
Sensitivity, Specificity, Positive predictive value and Negative predictive value of CyTb intradermal skin test for the diagnosis of cutaneous tuberculosisTimepoint: Baseline and 6 weeks—

Secondary

MeasureTime frame
Sensitivity, Specificity, Positive predictive value & Negative predictive value of TST (Tuberculin skin test) for the diagnosis of cutaneous tuberculosisTimepoint: Baseline & 6 weeks;Sensitivity, Specificity, Positive predictive value & Negative predictive value of IGRA for the diagnosis of cutaneous tuberculosisTimepoint: Baseline & 6 weeks—

Countries

India

Contacts

Public ContactDr Deepika Yadav

Maulana Azad Medical College

deepikayadav18.90@gmail.com9717825933

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026