drugset / Trial / NCT05622916
Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts
RandomizedParallel-groupSingle-blindTreatment
Summary
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%
Timeline
- Start
- 2022-11-30
- Primary completion
- 2023-02-28
- Completion
- 2023-04-30
Publications
- Background Sherrard J, Riddell L. Comparison of the effectiveness of commonly used clinic-based treatments for external genital warts. Int J STD AIDS. 2007 Jun;18(6):365-8. doi: 10.1258/095646207781024711.
- Background Gilson R, Nugent D, Werner RN, Ballesteros J, Ross J. 2019 IUSTI-Europe guideline for the management of anogenital warts. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1644-1653. doi: 10.1111/jdv.16522.
- Background Sazwi NN, Nalina T, Abdul Rahim ZH. Antioxidant and cytoprotective activities of Piper betle, Areca catechu, Uncaria gambir and betel quid with and without calcium hydroxide. BMC Complement Altern Med. 2013 Dec 11;13:351. doi: 10.1186/1472-6882-13-351.
- Background Pharm T, Hartini YS, Wahyuono S, Widyarini S, Yuswanto A. Hartini et al In vivo Immunomodulatory Effect and Histopathological Features of Mouse Liver and Kidney Treated with Neolignans Isolated from Red Betel (Piper crocatum Ruiz & Pav) Leaf. Tropical Journal of Pharmaceutical Research. 2014;13:1609-1614. doi:10.4314/tjpr.v13i10.6
- Background Bonin CM, Padovani CTJ, da Costa IP, Avila LS, Ferreira AMT, Fernandes CES, Dos Santos AR, Tozetti IA. Detection of regulatory T cell phenotypic markers and cytokines in patients with human papillomavirus infection. J Med Virol. 2019 Feb;91(2):317-325. doi: 10.1002/jmv.25312. Epub 2018 Sep 24.
- Background Xu Y, Zhu KJ, Zhu N, Jiang DH, Chen XZ, Cheng H. Expression of Foxp3+CD4+CD25+ regulatory T cells and Th1/Th2, Tc1/Tc2 profiles in the peripheral blood of patients with condyloma acuminatum. Clin Exp Dermatol. 2009 Mar;34(2):229-35. doi: 10.1111/j.1365-2230.2008.03001.x. Epub 2008 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Piper crocatum | Unknown | 30 % | Topical |
| Comparator | Trichloroacetic acid | Small molecule | 90 % | Topical |