Clinical trial · Interventional
Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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%
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Wart | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical Ethanol Extract (Piper crocatum) | Drug | — | UNRESOLVED |
| Trichloroacetic Acid Topical | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Daily topical application (twice/day, in the morning and 30-60 minutes before bed at night) for 56 days.
- interventionNames
- Drug: Topical Ethanol Extract (Piper crocatum)
- type
- ACTIVE_COMPARATOR
- label
- Comparison
- description
- Weekly application (1x/week) by the physician for 8 weeks
- interventionNames
- Drug: Trichloroacetic Acid Topical
Primary outcomes (4)
- measure
- Size of wart
- timeFrame
- Changes of wart size from baseline to week 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men and women diagnosed with external anogenital warts 2. Clinical lesions of Anogenital Wart at least 3 lesions with a size of 1-5 cm 3. 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, Exclusion Criteria: 1. Pregnant or lactating women 2. Lesions located in the external urethral orifice and vagina 3. 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
References
Publications (6)
- BACKGROUNDSherrard 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. PMID 17609022
- BACKGROUNDGilson 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. PMID 32735077
- BACKGROUNDSazwi 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. PMID 24330738
- BACKGROUNDPharm 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
- BACKGROUNDBonin 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. PMID 30192406
- BACKGROUNDXu 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. PMID 19077104