Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

November 14, 2022 updated by: Bumi Herman, Hasanuddin University

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

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%

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 76124
        • Wahidin Sudirohusodo General Hospital
        • Contact:
        • Principal Investigator:
          • Idrianti Idrus, MD
        • Principal Investigator:
          • Wresti Indriatmi, MD, PhD
        • Principal Investigator:
          • Franciscus D Suyatna, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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)
Topical ethanol extract of red betel leaves (Piper crocatum) 30% with the details of formulation on detailed description section
Other Names:
  • Red Betel Leaves
Active Comparator: Comparison
Weekly application (1x/week) by the physician for 8 weeks
Drug: Trichloroacetic Acid Topical
Trichloroacetic acid topical 90%
Other Names:
  • TCA 90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Size of wart
Time Frame: Changes of wart size from baseline to week 12
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)
Time Frame: 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
change of Foxp3+ regulatory T (Treg) expression from baseline to week 8
TGF-β1
Time Frame: change of TGF-β1 expression from baseline to week 8
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
Time Frame: change of IFN-γ expression from baseline to week 8
the expression of IFN-γ from the stained cells in anogenital wart lesion
change of IFN-γ expression from baseline to week 8

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reaction
Time Frame: any adverse event from baseline to week 12
any records of adverse reaction including inflammation, irritation or other systemic adverse event
any adverse event from baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Investigators

  • Principal Investigator: Wresti Indriatmi, MD. Ph.D, Indonesia University
  • Principal Investigator: Fransiscus Suyatna, MD. Ph.D, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 30, 2022

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

November 14, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1114222112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

de-identified data will be shared for specific purpose, including article review

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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