Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

NCT ID: NCT05622916

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-04-30

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%

Detailed Description

Study Design :

A randomized controlled trial

Population:

Diagnosed with Condyloma Acuminata (International Classification of Disease 10 code A.63.0)

Intervention period :

8 weeks of daily topical intervention with follow-up at week 12

Detailed formulation

1. Extraction of Piper crocatum with ethanol assisted in a microwave-assisted extraction (MAE)

2. The dissolution and active substances are separated by evaporation using a rotary evaporator to obtain the extract in the form of a thick solution

3. freeze-drying is performed to obtain a stable thick extract

4. preparation of ointment by adding formulation of ethanol extract of red betel leaves with 50 mg of white vaseline to achieve 30% concentration

Settings:

Outpatient care at the designated hospital

Participants:

Consecutive recruitment

Sample Size Estimation:

Following the formula of two different means, with the indicator, as follows:

1. Type 1 error 5%

2. Power of Study 80%

3. Assuming the effect size of cohen d (in reducing the size of warts) is 0.5

4. equal allocation between two arms total sample: 100 participants

Proposed analysis:

Intention to treat (ITT) with sensitivity and subgroup analysis

Conditions

Anogenital Wart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Topical Ethanol Extract (Piper crocatum)

Intervention Type: DRUG

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

Comparison

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

Group Type: ACTIVE_COMPARATOR

Trichloroacetic Acid Topical

Intervention Type: DRUG

Trichloroacetic acid topical 90%

Interventions

Topical Ethanol Extract (Piper crocatum)

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

Intervention Type: DRUG

Trichloroacetic Acid Topical

Trichloroacetic acid topical 90%

Intervention Type: DRUG

Other Intervention Names

Red Betel Leaves; TCA 90

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasanuddin University

OTHER

Sponsor Role: lead

Responsible Party

Bumi Herman

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Idrianti Idrus, MD

Role: PRINCIPAL_INVESTIGATOR

Hasanuddin University

Wresti Indriatmi, MD. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Fransiscus Suyatna, MD. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, Indonesia

Countries

Indonesia

Central Contacts

Idrianti Idrus, MD

Role: CONTACT

rasiah.05@gmail.com

+624118910174

Facility Contacts

Agussalim Bukhari, MD, Ph.D.

Role: primary

fkunhas@med.unhas.ac.id

+62 411 583333

References

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.

Reference Type: BACKGROUND

PMID: 17609022 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32735077 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24330738 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 30192406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19077104 (View on PubMed)

Other Identifiers

1114222112

Identifier Type: -

Identifier Source: org_study_id