Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

Trial Title: Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

NCT ID: NCT05622916

Condition: Anogenital Wart

Conditions: Official terms:
Warts
Condylomata Acuminata
Ethanol

Conditions: Keywords:
Anogenital Wart
Trichloroacetic
Piper crocatum
Clinical Efficacy
Inflammatory Marker

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: One group will receive the intervention, whereas the comparison group will receive standard care

Primary purpose: Treatment

Masking: Single (Participant)

Masking description: participants will be blind from the allocation by mimicking the topical solution

Intervention:

Intervention type: Drug
Intervention name: Topical Ethanol Extract (Piper crocatum)
Description: Topical ethanol extract of red betel leaves (Piper crocatum) 30% with the details of formulation on detailed description section
Arm group label: Intervention

Other name: Red Betel Leaves

Intervention type: Drug
Intervention name: Trichloroacetic Acid Topical
Description: Trichloroacetic acid topical 90%
Arm group label: Comparison

Other name: TCA 90

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

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Wahidin Sudirohusodo General Hospital

Address:
City: Makassar
Zip: 76124
Country: Indonesia

Contact:
Last name: Agussalim Bukhari, MD, Ph.D.

Phone: +62 411 583333
Email: fkunhas@med.unhas.ac.id

Investigator:
Last name: Idrianti Idrus, MD
Email: Principal Investigator

Investigator:
Last name: Wresti Indriatmi, MD, PhD
Email: Principal Investigator

Investigator:
Last name: Franciscus D Suyatna, MD, PhD
Email: Principal Investigator

Start date: November 30, 2022

Completion date: April 30, 2023

Lead sponsor:
Agency: Hasanuddin University
Agency class: Other

Source: Hasanuddin University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05622916