Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts
- Conditions
- Anogenital Wart
- Interventions
- Drug: Trichloroacetic Acid Topical
- Registration Number
- NCT05622916
- Lead Sponsor
- Hasanuddin University
- 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%
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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,
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparison Trichloroacetic Acid Topical Weekly application (1x/week) by the physician for 8 weeks Intervention Topical Ethanol Extract (Piper crocatum) Daily topical application (twice/day, in the morning and 30-60 minutes before bed at night) for 56 days.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Wahidin Sudirohusodo General Hospital
🇮🇩Makassar, South Sulawesi, Indonesia