NCT07072065

Impact Of Intralesional Tuberculin Ppd Injection On Anogenital

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Universitas Padjadjaran · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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)

Conditions

• Human Papilloma Virus
• Infections

Interventions

Type	Name	Description
DRUG	protein purified derivative	tuberculin purified protein derivative with dose 5 tuberculin unit

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-03-31
• Completion: 2023-07-31
• First posted: 2025-07-18
• Last updated: 2025-07-18

Locations

1 site across 1 country: Indonesia