Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

NCT05622916 | Unknown

• 1 other identifier: 1114222112
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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%

Conditions

Anogenital Wart

Keywords

Anogenital Wart; Trichloroacetic; Piper crocatum; Clinical Efficacy; Inflammatory Marker

Outcome Measures

Primary Outcomes (4)

• Size of wart

  the size of wart measured from the outermost edge of the warts.

  Changes of wart size from baseline to week 12

• Foxp3+ regulatory T (Treg)

  the expression of Foxp3+ regulatory T (Treg) from the stained T cells in anogenital wart lesion

  change of Foxp3+ regulatory T (Treg) expression from baseline to week 8

• TGF-β1

  the expression of TGF-β1 from the stained cells in anogenital wart lesion

  change of TGF-β1 expression from baseline to week 8

• IFN-γ

  the expression of IFN-γ from the stained cells in anogenital wart lesion

  change of IFN-γ expression from baseline to week 8

Other Outcomes (1)

• Adverse reaction

  any adverse event from baseline to week 12

Study Arms (2)

Intervention

EXPERIMENTAL

Daily topical application (twice/day, in the morning and 30-60 minutes before bed at night) for 56 days.

Drug: Topical Ethanol Extract (Piper crocatum)

Comparison

ACTIVE COMPARATOR

Weekly application (1x/week) by the physician for 8 weeks

Drug: Trichloroacetic Acid Topical

Interventions

Topical Ethanol Extract (Piper crocatum) DRUG

Topical ethanol extract of red betel leaves (Piper crocatum) 30% with the details of formulation on detailed description section

Also known as: Red Betel Leaves

Intervention

Trichloroacetic Acid Topical DRUG

Trichloroacetic acid topical 90%

Also known as: TCA 90

Comparison

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 76124, Indonesia

Location

Related Publications (6)

• 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.

  PMID: 17609022 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.

  PMID: 32735077 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.

  PMID: 24330738 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.

  PMID: 30192406 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.

  PMID: 19077104 BACKGROUND

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Ethanol; Trichloroacetic Acid

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Idrianti Idrus, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Wresti Indriatmi, MD. Ph.D

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Fransiscus Suyatna, MD. Ph.D

  Indonesia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idrianti Idrus, MD

CONTACT

+624118910174; rasiah.05@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants will be blind from the allocation by mimicking the topical solution
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: One group will receive the intervention, whereas the comparison group will receive standard care

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 21, 2022
• Study Start: November 30, 2022
• Primary Completion: February 28, 2023
• Study Completion: April 30, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)