Impact Of Intralesional Tuberculin Ppd Injection On Anogenital

NCT07072065 | Completed Phase 2 DMC

• 1 other identifier: DV-202506.02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Papilloma Virus; Infections

Outcome Measures

Primary Outcomes (5)

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

  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).

  Baseline and Week 2

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

  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

  Baseline and Week 2

• Percentage Reduction in AGW Lesion Volume

  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

  Baseline to Week 6

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

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

  Baseline and Week 6

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

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

  Baseline and Week 6

Study Arms (2)

AGW patient treated with PPD antigen injection

EXPERIMENTAL

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.

Drug: protein purified derivative

AGW patient

NO INTERVENTION

Lesion observation for 6 week

Interventions

protein purified derivative DRUG

tuberculin purified protein derivative with dose 5 tuberculin unit

AGW patient treated with PPD antigen injection

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• National University of Malaysia: collaborator

Study Sites (1)

Venereology Clinic, Dr. Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Infections

Interventions

Tuberculin

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 18, 2025
• Study Start: April 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)