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Completed

NCT Number: NCT07072065

Impact Of Intralesional Tuberculin Ppd Injection On Anogenital

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.

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Key information

Conditions

Human Papilloma Virus Infections

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Venereology Clinic, Dr. Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

About this study

The research was conducted, in the STIs clinic at the Department of Dermatology and Venereology, Dr. Hasan Sadikin Hospital Bandung. The specimen was taken from 12 patients with AGW who have been previously treated with TPPD intralesional therapy, and 12 patients with AGW which not treated with TPPD as a control, from previous research titled which has received ethical clearance from Dr. Hasan Sadikin Hospital Bandung No. LB.02.01/X.6.5/291/2019.

The research inclusion criteria include specimen taken from patient with HPV infection in the anogenital area who have previously demonstrated a response to a 2 TU (0.1 ml) intradermal PPD antigen injection on the left forearm, with a minimum induration of 5 mm observed within 48-72 hours, and patients who were 12 years of age or older. Exclusion criteria include specimen from patient with a history of severe hypersensitivity reactions, such as anaphylaxis, to PPD antigen; pregnant or breastfeeding women; or who have received any other AGW treatments in the two to three months prior; those with immunosuppressive conditions or those who are taking immunosuppressive medications; patients with a history of asthma or other allergic conditions, as well as those experiencing active infections or other systemic illnesses; and patients with a history of keloids or seizures. The PPD group received intralesional TPPD therapy, administering 5 TU (0,25 ml of PPD-2TU) to the largest AGW lesion once a week for six consecutive injections. The technique involved positioning the syringe needle parallel to the skin surface, with the bevel facing upward. Evaluation of IFN-α and IL-2 expression was performed on AGW tissue and serum samples from AGW patients in the TPPD-treated group, both before and after therapy. Tissue cytokine expression was assessed after the second injection (week 2), while serum cytokine levels were measured after the sixth injection (week 6)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

protein purified derivative

Drug

tuberculin purified protein derivative with dose 5 tuberculin unit

Primary outcomes

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

    Time frame: Baseline and Week 2

    Quantification of IFN-α positive lymphocytes in anogenital wart (AGW) tissue samples using immunohistochemistry. The average number of IFN-α positive cells will be calculated from three high-power fields (400× magnification).

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

    Time frame: Baseline and Week 2

    Quantification of IL-2 positive lymphocytes in AGW tissue samples using immunohistochemistry. Results are expressed as the mean number of positive cells across three high-power fields

  3. Percentage Reduction in AGW Lesion Volume

    Time frame: Baseline to Week 6

    Lesion volume reduction calculated using the formula:

    [(Baseline Volume - Volume at Week 6) / Baseline Volume] × 100%.

    Therapeutic response will be classified as:

    No response: 0% reduction

    Minimal response: <50% reduction

    Partial response: 50-99% reduction

    Complete response: 100% reduction

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

    Time frame: Baseline and Week 6

    Concentration of IFN-α in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.

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

    Time frame: Baseline and Week 6

    Concentration of IL-2 in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Collaborators

  • National University of Malaysia

Registry information

Official study title

Impact of Intralesional Tuberculin PPD Injection on Anogenital Warts: Interferon-Α, Interleukin-2, And Treatment Outcomes

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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