Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts

Sponsor

Hasanuddin University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05622916

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

20.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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%

Condition or Disease	Intervention/Treatment	Phase
Anogenital Wart	Drug: Topical Ethanol Extract (Piper crocatum) Drug: Trichloroacetic Acid Topical	N/A

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

One group will receive the intervention, whereas the comparison group will receive standard careOne group will receive the intervention, whereas the comparison group will receive standard care

Masking:

Single (Participant)

Masking Description:

participants will be blind from the allocation by mimicking the topical solution

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Size of wart [Changes of wart size from baseline to week 12]
the size of wart measured from the outermost edge of the warts.
Foxp3+ regulatory T (Treg) [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
TGF-β1 [change of TGF-β1 expression from baseline to week 8]
the expression of TGF-β1 from the stained cells in anogenital wart lesion
IFN-γ [change of IFN-γ expression from baseline to week 8]
the expression of IFN-γ from the stained cells in anogenital wart lesion

Other Outcome Measures

Adverse reaction [any adverse event from baseline to week 12]
any records of adverse reaction including inflammation, irritation or other systemic adverse event

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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