Infections

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Warts

Condylomata Acuminata

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

All Drugs and Chemicals

Cantharidin

Enzyme Inhibitors

Application of cantharidine to perenial warts

application of trichloroacetic acid to perenial warts

A thin film of cantharidin is applied to the surface of the wart and to 1 millimeter area surrounding the wart. After the film dries, it is covered with an occlusive dressing for 24 hours. The patient removes the area the next day and thoroughly washes the area with soap and water. Patients return to clinic a week later.

Trichloroacetic acid is applied to the surface of the wart with a wooden applicator and after drying the area is washed with soap and water in an hour.

Trichloroacetic Acid

Comparison of trichloroacetic acid versus cantharidine for the treatment of perenial warts.

Warts are one of the most common sexually transmitted diseases. They are caused by the human papilloma virus (HPV) that causes cervical cancer. Warts can grow, obstruct labor, and spread. Patients presenting to the obgyn clinic with perenial warts were randomized to treatment with trichloroacetic acid (one of the many types of treatments) or to the treatment with cantharidine group. Cantharidine is a vesicant extracted from beetle bugs which painlessly causes a small blister to form and cures the patient from the HPV infection causing the wart . We compared cosmesis, scar formation, pain and number of treatments (visits) as well as effectiveness in both groups.

Objectives

1. Determine if cantharone is more effective than trichloroacetic acid (TCA) for removal of warts
2. Compare pain levels (pain during application) for each method
3. Compare patient satisfaction for each method
4. Compare scar formation and cosmesis for each method

Patients will be randomized to receive either trichloroacetic acid or cantharidine treatment.

Patients will be randomized to receive treatment with trichloroacetic acid or cantharidine.

This is a study on perenial genital warts, near the vulvovaginal area. Only women have vulvovaginas.

Cantharone for the Treatment of Perenial Warts

Trichloroacetic Acid Versus Cantharone for the Treatment of Perenial Warts

Comparison of pain when treatment is applied. The patient is asked on a scale of 0-5 (with 5 being extreme pain, 4 being severe pain, 3 being moderate, 2 being mild, 1 being slight and zero being no pain, how do you rate your pain.

A questionnaire given to the patient at the conclusion of the study and containing the question "on a scale from 1-5 (5 most likely) how likely are you to recommend this method to a friend or using it again yourself".

At the time of wart eradication, the treatment area is examined for healing. The clinician rates cosmesis on a scale from 0-5 with 5-skin grows back perfectly, 4-slight discoloration, 3-thickened skin, 1-slight scarring and 0-scarring.

University of California, San Francisco

St Vincent's Hospital

Wayne State University

Assistant Professor, Clinical Educator

Anti-Inflammatory Agents

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Anti-Infective Agents

Curcumin

Interferons

Interferon-gamma

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Participants received a dosage of 200mg capsules with active ingredient /Nanocurcumin per day after breakfast, for 8 weeks.

Participants received a dosage of 200mg capsules without Nanocurcumin per day after breakfast, for 8 weeks

Curcumin oral capsule in nano-sized particle.

Curcumin Oral Capsule

Trichloroacetic acid

Blood sample collection

Cotton swab for collecting sample from AGW lesions.

Cotton swab

Hernayati Hutabarat

The goal of this clinical trial is to demonstrate the adjuvant administration of oral nanocurcumin in 90% TCA therapy that increases the proportion of clinical improvement in patients with Anogenital Warts (AGW), mediated by NFĸB, IFN-γ, and FOXP3+Treg. Specific objectives of this clinical trial include:

* To prove that the oral administration of nanocurcumin decreases the levels of IFN-γ, FOXP3+Treg, and NFĸB in lesions of AGW patients, and
* To demonstrate that the reduction in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions is associated with the proportion of clinical improvement in AGW patients undergoing TCA 90% therapy with adjuvant of oral nanocurcumin.

The main questions it aims to answer are:

* Does adjuvant oral nanocurcumin administration in 90% TCA therapy increase the proportion of clinical improvement in patients with AGW compared to controls (90% TCA therapy alone)?
* Is there a greater decrease in IFN-γ, FOXP3+Treg, and NFĸB levels in lesions of patients with AGW given adjuvant oral nanocurcumin compared to controls?
* Is the decrease in IFN-γ, FOXP3+TReg, and NFĸB levels in lesions of patients with AGW, with adjunctive oral nanocurcumin administration in 90% TCA therapy, associated with the degree of clinical improvement in patients with AGW?

Participants will be divided into 2 groups. The first one was given capsules without active ingredients/nanocurcumin (control group), and the second one was given capsules with nanocurcumin (experimental group), both group received a dosage of 200mg capsules per day after breakfast, for 8 weeks. The researchers conducted a comparison between those 2 groups to assess whether the adjuvant administration of oral nanocurcumin in 90% TCA therapy enhances the proportion of clinical improvement in patients with AGW.

The study is expected to enhance various aspects, including education, healthcare services, and research development aspects. This research aims to improve the understanding of the efficacy of oral nanocurcumin administration in patients with AGW and its implications on clinical aspects and its biomarkers (IFN-γ, Treg FOXP3+, and NF-kB levels) in AGW lesions. Therefore, it is anticipated to enhance the clinical improvement of the patients, potentially reducing the transmission rate of the disease. Furthermore, this study serves as a foundation for the development of future therapies for patients with AGW, opening avenues for further research endeavors, and exploring traditional medicine as a medical therapy with a robust evidence base.

Subjects were obtained from multiple centers in Indonesia, predominantly in Jakarta and nearby the area, such as, from the Dermatology \& Venereology outpatient clinic at Dr Cipto Mangunkusumo hospital, HIV and STI Clinics at Tambora Health Center (CINTTA Clinic), Penjaringan Health Center, Kalideres Health Center, Taman Sari Health Center, Cengkareng Health Center, and several foundations that provide care for HIV and STI patients. The acetic acid testing was conducted to confirm the diagnosis of AGW.

Lesions meeting the research criteria (a minimum of 3 lesions, and the diameter of at least one lesion is between 5 mm to under 50 mm) continued to be treated with 90% TCA solution. If participants had giant AGW lesions, they were referred to the Surgery outpatient clinic at Dr Cipto Mangunkusumo hospital for further management. Participants underwent 8 weekly visits.

Sample collection and drug administration protocol included: sample collection using wet cotton swabs swiped on the lesion for biomarkers (IFN-γ, FOXP3+TReg, and NFĸB) examination, as well as blood collection for HIV and CD4+ examination at week 1, 4, and 8, application of 90% TCA solution + nanocurcumin/control capsule administration at every visit for 8 weeks, along with control and clinical evaluation / side effect assessment. If lesions were no longer visible and the acetic acid test was negative by week 8, the lesions were considered healed and no further application of 90% TCA solution was conducted, but biomarkers examination continued. If lesions were still visible, application would continue until lesions were healed, with treatment continued at a center accessible to the patient. Participants who tested positive for HIV were referred to the HIV outpatient clinic for appropriate treatment.

Additional details related to the drug administration and sample collection protocol included:

* Participants were provided with information sheets on how to consume the medication and instructed on its usage and were required to fill out a Medication Diary every time they took the medication, experienced lapses, or developed any complaints.
* In case of non-compliance or lapses, patients were asked to write down and report to the contact number listed in the Diary.
* To reduce discomfort, the skin swabbing process was performed carefully and with sufficient time. Each patient was provided with Gentamicin cream to take home, in case of unwanted infections occurring at home, and were instructed to report to the researcher for further management.
* In case of side effects such as allergic reactions, nausea, vomiting, abdominal pain, or severe headaches, patients were instructed to report and discontinue medication consumption. They were provided with medication to alleviate symptoms and considered dropouts.
* Medications were provided for side effects including mild allergic reactions. For severe allergic reactions, participants were advised to immediately go to the nearest Emergency Department for management and the researcher would accompany them.
* The education provided to the participants included the following: scheduled follow-up visits every 7 days after therapy, postponement of sexual intercourse or the use protection (condoms), Counseling regarding the possibility of HIV and other STI transmission risks for themselves and their sexual partners, recommendation for pap smear examinations every 3 years for women aged 21 years and older, and Informing the sexual partners of the participants about the possibility of transmission even in the absence of visible lesions and encouraging them to undergo examinations.

The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue

The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, Nuclear Factor Kappa-Light-Chain-Enchancer of Activated B Cells, Interferon-γ, and FOXP3+ Regulatory T Cell From Lesions Tissue

The percentage reduction in the volume of AGW lesions in visit 8 compared to the initial volume.

* Decrease of IFN-γ level in lesions of AGW patients
* reduction in IFN-γ level in lesions is associated with the proportion of clinical improvement in AGW patients

* Decreases of FOXP3+Treg level in lesions of AGW patients
* reduction in FOXP3+Treg level in lesions is associated with the proportion of clinical improvement in AGW patients

* Decreases of NFĸB level in lesions of AGW patients
* reduction in NFĸB level in lesions is associated with the proportion of clinical improvement in AGW patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cantharone for the Treatment of Perenial Warts	NCT03625960	Wart, Genital	Cantharidin Trichloroacetic...	18 Years - 75 Years	Wayne State University
The Effect of Oral Nanocurcumin as an Adjuvant Therapy for Anogenital Warts: Evaluation of Clinical Improvement, NFĸB, IFN-γ, and FOXP3+TReg From Lesions Tissue	NCT06281353	Anogenital Wart	Curcumin Oral C... Trichloroacetic... Blood sample co... Cotton swab	18 Years - 60 Years	Indonesia University

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