Anogenital Wart
Conditions
Keywords
Anogenital Wart, Trichloroacetic, Piper crocatum, Clinical Efficacy, Inflammatory Marker
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
Interventions
DRUGTopical Ethanol Extract (Piper crocatum)
Topical ethanol extract of red betel leaves (Piper crocatum) 30% with the details of formulation on detailed description section
Trichloroacetic acid topical 90%
Sponsors
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
participants will be blind from the allocation by mimicking the topical solution
Intervention model description
One group will receive the intervention, whereas the comparison group will receive standard care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse reaction | any adverse event from baseline to week 12 | any records of adverse reaction including inflammation, irritation or other systemic adverse event |
Countries
Indonesia
Contacts
Primary ContactIdrianti Idrus, MD
Outcome results
None listed