Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

Hasanuddin University

Status: Not yet enrolling

Conditions: Anogenital Wart

Treatments: Drug: Trichloroacetic Acid Topical; Drug: Topical Ethanol Extract (Piper crocatum)

Study type: Interventional

Funder types: Other

Identifiers

NCT05622916

1114222112

Details and patient eligibility

About

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%

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Topical Ethanol Extract (Piper crocatum)

Comparison

Active Comparator group

Description:

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

Treatment:

Drug: Trichloroacetic Acid Topical