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 | Completed Phase 2 DMC

• 1 other identifier: 22-07-0754
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anogenital Wart

Keywords

anogenital wart; nanocurcumin; Interferon-γ; NFkB; FOXP3+TReg; cotton swab; adjuvant

Outcome Measures

Primary Outcomes (1)

• Clinical improvement in patients with AGW

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

  7 weeks

Secondary Outcomes (3)

• Level of IFN-γ in lesions of AGW patients

  7 weeks

• Level of FOXP3+Treg in lesions of AGW patients

  7 weeks

• Level of NFĸB in lesions of AGW patients

  7 weeks

Study Arms (2)

Capsules with active ingredient /Nanocurcumin

EXPERIMENTAL

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

Drug: Curcumin Oral Capsule; Drug: Trichloroacetic acid; Procedure: Blood sample collection; Procedure: Cotton swab

Placebo

PLACEBO COMPARATOR

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

Drug: Trichloroacetic acid; Procedure: Blood sample collection; Procedure: Cotton swab

Interventions

Curcumin Oral Capsule DRUG

Curcumin oral capsule in nano-sized particle.

Also known as: Nanocurcumin Oral Capsule

Capsules with active ingredient /Nanocurcumin

Trichloroacetic acid DRUG

TCA 90%

Also known as: TCA 90%

Capsules with active ingredient /Nanocurcumin; Placebo

Blood sample collection PROCEDURE

HIV and CD4+ 4th generation.

Capsules with active ingredient /Nanocurcumin; Placebo

Cotton swab PROCEDURE

Cotton swab for collecting sample from AGW lesions.

Capsules with active ingredient /Nanocurcumin; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female aged 18-60 years.
• Clinically diagnosed with anogenital warts (AGW) with typical features and positive acetic acid test.
• Have AGW lesions in the extragenital and/or perianal area, with a minimum of 3 lesions, and the diameter of at least one lesion is between 5 mm to under 50 mm.
• Have not received AGW therapy within the last 2 weeks.
• Agree to participate in the study, including all laboratory sample collection procedures, and sign an informed consent form.

You may not qualify if:

• Infection within AGW lesions, ulceration, or suspicion of malignancy, and/or currently experiencing fever or other systemic infections.
• Patients with a history of autoimmune diseases.
• History of allergy or severe adverse reactions to curcumin/turmeric.
• Patients with blood coagulation disorders.
• History of malignancy.
• Consumption of steroid and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, mefenamic acid, diclofenac, aspirin, paracetamol, and antalgic, for a minimum of 3 days prior to the study.
• Consumption of traditional or modern herbal remedies or supplements for a minimum of 7 days prior to the study.
• Use of immunomodulatory drugs (e.g., isoprinosine) for a minimum of 7 days prior to the study.
• Oral corticosteroid use for a minimum of 2 weeks prior to the study.
• Pregnancy and breastfeeding.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (1)

• Radi NKR RS, Khadium IAA, Hamood SS, Nadaabudellahkerbel. Evaluation of Gamma Interferon and Interleukin 10 Levels at Patient with Genital Wart, Iraq. Biochem Cell Arch. 2018;18:1083-6.

  BACKGROUND

MeSH Terms

Conditions

Condylomata Acuminata

Interventions

Curcumin; nanocurcumin; Trichloroacetic Acid

Condition Hierarchy (Ancestors)

Papillomavirus Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Chloroacetates; Acetates; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated

Study Officials

• Hernayati Hutabarat

  Faculty of medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatovenereologist, Principal Investigator

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: August 16, 2022
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)