CompletedPhase 2

Impact Of Intralesional Tuberculin Ppd Injection On Anogenital

Indonesia24 participantsStarted 2022-04-01

Plain-language summary

This clinical study investigates the immunological effects of tuberculin purified protein derivative (TPPD) therapy in patients with anogenital warts (AGW) caused by human papillomavirus (HPV). Twelve AGW patients received intralesional TPPD injections (5 tuberculin units) once weekly for six weeks and were compared with twelve control patients. Tissue samples were collected at baseline and after two injections for immunohistochemical analysis of interferon-alpha (IFN-α) and interleukin-2 (IL-2) expression. Blood samples were collected at baseline and after six injections to measure serum levels of IFN-α and IL-2 using ELISA. The study aims to evaluate TPPD as a potential immunotherapeutic agent by assessing cytokine responses associated with AGW regression.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with HPV infection in the anogenital area. * Prior positive response to a 2 TU (0.1 mL) intradermal PPD antigen injection on the left forearm, indicated by a minimum induration of 5 mm within 48-72 hours. * Age 12 years or older. Exclusion Criteria: * History of severe hypersensitivity reactions (e.g., anaphylaxis) to PPD antigen. * Pregnant or breastfeeding women. * Received any other AGW treatments within the past 2-3 months. * Immunosuppressive conditions or currently taking immunosuppressive medications. * History of asthma or other allergic conditions. * Presence of active infections or other systemic illnesses. * History of keloids or seizures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC)

Timeframe: Baseline and Week 2

Change in Tissue IL-2 Expression in AGW Lesions (Measured by IHC)

Timeframe: Baseline and Week 2

Percentage Reduction in AGW Lesion Volume

Timeframe: Baseline to Week 6

Change in Serum IFN-α Levels (Measured by ELISA)

Timeframe: Baseline and Week 6

Change in Serum IL-2 Levels (Measured by ELISA)

Timeframe: Baseline and Week 6

Trial details

NCT IDNCT07072065

SponsorUniversitas Padjadjaran

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-31

View on ClinicalTrials.gov More Human Papilloma Virus trials

Plain-language summary

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC)

Timeframe: Baseline and Week 2

Change in Tissue IL-2 Expression in AGW Lesions (Measured by IHC)

Timeframe: Baseline and Week 2

Percentage Reduction in AGW Lesion Volume

Timeframe: Baseline to Week 6

Change in Serum IFN-α Levels (Measured by ELISA)

Timeframe: Baseline and Week 6

Change in Serum IL-2 Levels (Measured by ELISA)

Timeframe: Baseline and Week 6