The Efficacy of Ethanol Extract of Red Betel Leaves (Piper Crocatum) as Topical Patient-Applied Therapy In Anogenital Warts The Study of Foxp3+ Treg, Tumor Growth Factor (TGF)-β1, and Interferon (IFN)-γ Expression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Size of wart
研究概览
简要总结
This clinical trial aims to assess the efficacy of topical Piper crocatum in treating Anogenital warts. It aims to answer
- the clinical efficacy of treating anogenital warts
- the expression of Foxp3+ regulatory T (Treg), TGF/Tumor Growth Factor -β1, and IFN/interferon -γ of anogenital wart lesion Participants will be allocated into two topical treatments, intervention and active comparator Trichloroacetic Acid (TCA) 90%. The researchers assume that intervention is superior compared to TCA 90%
详细描述
Study Design :
A randomized controlled trial
Population:
Diagnosed with Condyloma Acuminata (International Classification of Disease 10 code A.63.0)
Intervention period :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
participants will be blind from the allocation by mimicking the topical solution
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women diagnosed with external anogenital warts
- •Clinical lesions of Anogenital Wart at least 3 lesions with a size of 1-5 cm
- •In patients with HIV, Cluster of Differentiation 4 (CD4)cell count >350 cells/mm and have been taking antiretroviral (ARV) drugs regularly for 3 months,
排除标准
- •Pregnant or lactating women
- •Lesions located in the external urethral orifice and vagina
- •Using systemic immunomodulators/immunosuppressants
- •The protocol treatment will be discontinued if patients
- •a. Withdraw their consent based on the patient's demand d. Severe adverse events occurred or allergies to the components of the test product b. After undergoing clinical trials, the patient experienced things that caused him/her to no longer meet the criteria set out in this protocol. c. Subjects do not comply the established study protocol
研究组 & 干预措施
Intervention
Daily topical application (twice/day, in the morning and 30-60 minutes before bed at night) for 56 days.
干预措施: Topical Ethanol Extract (Piper crocatum) (Drug)
Comparison
Weekly application (1x/week) by the physician for 8 weeks
干预措施: Trichloroacetic Acid Topical (Drug)
结局指标
主要结局
Size of wart
时间窗: Changes of wart size from baseline to week 12
the size of wart measured from the outermost edge of the warts.
Foxp3+ regulatory T (Treg)
时间窗: change of Foxp3+ regulatory T (Treg) expression from baseline to week 8
the expression of Foxp3+ regulatory T (Treg) from the stained T cells in anogenital wart lesion
TGF-β1
时间窗: change of TGF-β1 expression from baseline to week 8
the expression of TGF-β1 from the stained cells in anogenital wart lesion
IFN-γ
时间窗: change of IFN-γ expression from baseline to week 8
the expression of IFN-γ from the stained cells in anogenital wart lesion
次要结局
未报告次要终点
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University