Anogenital WartNCT05622916
Topical Ethanol Extract (Piper Crocatum) for Anogenital Warts
A study testing Topical Ethanol Extract (Piper crocatum) and Trichloroacetic Acid Topical in people with Anogenital Wart, run by Hasanuddin University at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anogenital Wart
- What is being tested?
- Topical Ethanol Extract (Piper crocatum) and Trichloroacetic Acid Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Nov 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, 76124
Agussalim Bukhari, MD, Ph.D., +62 411 583333, fkunhas@med.unhas.ac.id
Idrianti Idrus, MD
About this study
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
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%
Read the 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
- Conditions
- Anogenital Wart
- Being tested
- Topical Ethanol Extract (Piper crocatum), Trichloroacetic Acid Topical
- Keywords
- Anogenital Wart, Trichloroacetic, Piper crocatum, Clinical Efficacy, Inflammatory Marker
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Ethanol Extract (Piper crocatum)Drug
Also called Red Betel Leaves
Topical ethanol extract of red betel leaves (Piper crocatum) 30% with the details of formulation on detailed description section
Trichloroacetic Acid TopicalDrug
Also called TCA 90
Trichloroacetic acid topical 90%
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Daily topical application (twice/day, in the morning and 30-60 minutes before bed at night) for 56 days. Receives: Drug: Topical Ethanol Extract (Piper crocatum) |
| Comparison | Active comparator | Weekly application (1x/week) by the physician for 8 weeks Receives: Drug: Trichloroacetic Acid Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of wart
the size of wart measured from the outermost edge of the warts.
Measured: Changes of wart size from baseline to week 12
Foxp3+ regulatory T (Treg)
the expression of Foxp3+ regulatory T (Treg) from the stained T cells in anogenital wart lesion
Measured: change of Foxp3+ regulatory T (Treg) expression from baseline to week 8
TGF-β1
the expression of TGF-β1 from the stained cells in anogenital wart lesion
Measured: change of TGF-β1 expression from baseline to week 8
IFN-γ
the expression of IFN-γ from the stained cells in anogenital wart lesion
Measured: change of IFN-γ expression from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start30 Nov 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anogenital WartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive the intervention, whereas the comparison group will receive standard care
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bumi Herman, Hasanuddin University
- Investigators
- Idrianti Idrus, MD, Principal investigator, Hasanuddin UniversityWresti Indriatmi, MD. Ph.D, Principal investigator, Universitas IndonesiaFransiscus Suyatna, MD. Ph.D, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622916
- Sponsor's protocol ID
- 1114222112
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: de-identified data will be shared for specific purpose, including article review
Publications
Sherrard J, Riddell L. Comparison of the effectiveness of commonly used clinic-based treatments for external genital warts. Int J STD AIDS. 2007 Jun;18(6):365-8. doi: 10.1258/095646207781024711.
PubMed 17609022Gilson R, Nugent D, Werner RN, Ballesteros J, Ross J. 2019 IUSTI-Europe guideline for the management of anogenital warts. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1644-1653. doi: 10.1111/jdv.16522.
PubMed 32735077Sazwi NN, Nalina T, Abdul Rahim ZH. Antioxidant and cytoprotective activities of Piper betle, Areca catechu, Uncaria gambir and betel quid with and without calcium hydroxide. BMC Complement Altern Med. 2013 Dec 11;13:351. doi: 10.1186/1472-6882-13-351.
PubMed 24330738Pharm T, Hartini YS, Wahyuono S, Widyarini S, Yuswanto A. Hartini et al In vivo Immunomodulatory Effect and Histopathological Features of Mouse Liver and Kidney Treated with Neolignans Isolated from Red Betel (Piper crocatum Ruiz & Pav) Leaf. Tropical Journal of Pharmaceutical Research. 2014;13:1609-1614. doi:10.4314/tjpr.v13i10.6
Bonin CM, Padovani CTJ, da Costa IP, Avila LS, Ferreira AMT, Fernandes CES, Dos Santos AR, Tozetti IA. Detection of regulatory T cell phenotypic markers and cytokines in patients with human papillomavirus infection. J Med Virol. 2019 Feb;91(2):317-325. doi: 10.1002/jmv.25312. Epub 2018 Sep 24.
PubMed 30192406Xu Y, Zhu KJ, Zhu N, Jiang DH, Chen XZ, Cheng H. Expression of Foxp3+CD4+CD25+ regulatory T cells and Th1/Th2, Tc1/Tc2 profiles in the peripheral blood of patients with condyloma acuminatum. Clin Exp Dermatol. 2009 Mar;34(2):229-35. doi: 10.1111/j.1365-2230.2008.03001.x. Epub 2008 Dec 2.
PubMed 19077104
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05622916
- Acronym / sponsor ID
- 1114222112
- Conditions
- Anogenital Wart
- Keywords
- Anogenital Wart, Trichloroacetic, Piper crocatum, Clinical Efficacy, Inflammatory Marker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One group will receive the intervention, whereas the comparison group will receive standard care
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Topical Ethanol Extract (Piper crocatum)Daily topical application (twice/day, in the morning and 30-60 minutes before bed at night) for 56 days. |
| Comparison | Active comparator | Drug: Trichloroacetic Acid TopicalWeekly application (1x/week) by the physician for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Ethanol Extract (Piper crocatum)Also: Red Betel LeavesTopical ethanol extract of red betel leaves (Piper crocatum) 30% with the details of formulation on detailed description section | Drug | Intervention |
| Trichloroacetic Acid TopicalAlso: TCA 90Trichloroacetic acid topical 90% | Drug | Comparison |
Primary outcome
Size of wart
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: change of IFN-γ expression from baseline to week 8
the expression of IFN-γ from the stained cells in anogenital wart lesion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 17609022Sherrard J, Riddell L. Comparison of the effectiveness of commonly used clinic-based treatments for external genital warts. Int J STD AIDS. 2007 Jun;18(6):365-8. doi: 10.1258/095646207781024711.
- Background: PubMed 32735077Gilson R, Nugent D, Werner RN, Ballesteros J, Ross J. 2019 IUSTI-Europe guideline for the management of anogenital warts. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1644-1653. doi: 10.1111/jdv.16522.
- Background: PubMed 24330738Sazwi NN, Nalina T, Abdul Rahim ZH. Antioxidant and cytoprotective activities of Piper betle, Areca catechu, Uncaria gambir and betel quid with and without calcium hydroxide. BMC Complement Altern Med. 2013 Dec 11;13:351. doi: 10.1186/1472-6882-13-351.
- BackgroundPharm T, Hartini YS, Wahyuono S, Widyarini S, Yuswanto A. Hartini et al In vivo Immunomodulatory Effect and Histopathological Features of Mouse Liver and Kidney Treated with Neolignans Isolated from Red Betel (Piper crocatum Ruiz & Pav) Leaf. Tropical Journal of Pharmaceutical Research. 2014;13:1609-1614. doi:10.4314/tjpr.v13i10.6
- Background: PubMed 30192406Bonin CM, Padovani CTJ, da Costa IP, Avila LS, Ferreira AMT, Fernandes CES, Dos Santos AR, Tozetti IA. Detection of regulatory T cell phenotypic markers and cytokines in patients with human papillomavirus infection. J Med Virol. 2019 Feb;91(2):317-325. doi: 10.1002/jmv.25312. Epub 2018 Sep 24.
- Background: PubMed 19077104Xu Y, Zhu KJ, Zhu N, Jiang DH, Chen XZ, Cheng H. Expression of Foxp3+CD4+CD25+ regulatory T cells and Th1/Th2, Tc1/Tc2 profiles in the peripheral blood of patients with condyloma acuminatum. Clin Exp Dermatol. 2009 Mar;34(2):229-35. doi: 10.1111/j.1365-2230.2008.03001.x. Epub 2008 Dec 2.
- Individual participant dataSharing planned: No. de-identified data will be shared for specific purpose, including article review
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idrianti Idrus, MD principal investigator
Hasanuddin University
Wresti Indriatmi, MD. Ph.D principal investigator
Universitas Indonesia
Fransiscus Suyatna, MD. Ph.D principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Ethanol Extract (Piper crocatum) and Trichloroacetic Acid Topical in people with Anogenital Wart, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Idrianti Idrus, MD (+624118910174, rasiah.05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of wart (time frame: Changes of wart size from baseline to week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05622916, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.