Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

Study Overview
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Brief Summary
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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
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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 Extraction of Piper crocatum with ethanol assisted in a microwave-assisted extraction (MAE) The dissolution and active substances are separated by evaporation using a rotary evaporator to obtain the extract in the form of a thick solution freeze-drying is performed to obtain a stable thick extract 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: Type 1 error 5% Power of Study 80% Assuming the effect size of cohen d (in reducing the size of warts) is 0.5 equal allocation between two arms total sample: 100 participants Proposed analysis: Intention to treat (ITT) with sensitivity and subgroup analysis

Official Title
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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

Conditions
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Anogenital Wart

Intervention / Treatment
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* Drug: Topical Ethanol Extract (Piper crocatum)
* Drug: Trichloroacetic Acid Topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive the intervention, whereas the comparison group will receive standard care
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anogenital Wart, Trichloroacetic, Piper crocatum, Clinical Efficacy, Inflammatory Marker