Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

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 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

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