Impact of Intralesional Tuberculin PPD Injection on Anogenital Warts: Interferon-Α, Interleukin-2, And Treatment Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AGW patient treated with PPD antigen injection
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.
干预措施: protein purified derivative (Drug)
结局指标
主要结局
Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC)
时间窗: 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).
Change in Tissue IL-2 Expression in AGW Lesions (Measured by IHC)
时间窗: 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
Percentage Reduction in AGW Lesion Volume
时间窗: 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
Change in Serum IFN-α Levels (Measured by ELISA)
时间窗: Baseline and Week 6
Concentration of IFN-α in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.
Change in Serum IL-2 Levels (Measured by ELISA)
时间窗: Baseline and Week 6
Concentration of IL-2 in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.
次要结局
未报告次要终点
