Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts

Trial Title: Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts

NCT ID: NCT06077032

Condition: Non-Genital Warts

Conditions: Official terms:
Warts
Chlorhexidine
Pharmaceutical Solutions

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: garlic extract (15%) solution
Description: •Group 1: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with garlic extract (15%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.
Arm group label: garlic extract

Intervention type: Drug
Intervention name: topical chlorhexidine (2%) solution
Description: •Group 2: will apply Vaseline over the normal skin surrounding the lesion(s) then a cotton soaked with topical chlorhexidine (2%) solution will be applied under occlusion with a plastic tape for one hour and then washed by tap water daily for 6 weeks.
Arm group label: chlorhexidine

Intervention type: Drug
Intervention name: Saline
Description: •Group 3: (control) will use normal saline 0.9% as a placebo (they will be treated later on after completion of the study using any of the standard therapies for non-genital warts).
Arm group label: group3

Other name: saline 0.9%

Summary: Aim(s) of the Research: 1. Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts. 2. Explore possible relation between therapeutic response with demographic/clinical data. 3. Identify patients satisfaction with each agent.

Detailed description: Cutaneous warts or verruca are common, benign skin growths caused by human papilloma virus (HPV). There are several therapeutic modalities for warts: include destructive agents (keratolytics, cryotherapy, curettage and cautery, laser, photodynamic therapy), antimitotic agents (podophyllin, bleomycin, retinoids), immune stimulants (topical sensitizers, cimetidine), and topical virucidal agents (formaldehyde, glutaraldehyde) Unfortunately, no single treatment is satisfactory for all patients. Chlorhexidine gluconate(CHX) is a gluconate salt with a broad-spectrum antiseptic action against Gram-Positive, Gram-negative bacteria, aerobes, facultative anaerobes, and fungi such action is mediated through increasing the permeability of the cell walls of microbes, causing their lysis. Additionally, evidence indicates an in vitro effect against many viruses such as influenza A, parainfluenza, herpes virus 1, cytomegalovirus, hepatitis B, HIV and SARS-CoV-2. It was hypothesized that the biophysiological mechanisms for the virucidal effect of CHX may be exerted through lysis of viral envelope, deterioration of nucleotide carbon chains, and inactivation and/or blocking of viral proteins. Garlic (Allium sativum) is one of the most widely used medicinal plants with high therapeutic effects. Clinical effectiveness of oral and topical garlic extract may be attributed to its antimicrobial, antioxidant, anti-inflammatory, anticancer and aging prevention effects. However, the mechanisms of these actions are not clearly known. In vitro studies on garlic showed that garlic may enhance natural killer (NK) cells, which are an important part of the immune system in fighting cancers, viruses and certain bacteria. Previous studies showed garlic extract was effective on complete resolution of cutaneous wart. Chlorhexidine has not been used for treatment of warts in previous studies so we decided to explore its efficacy in treatment of warts.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients with the clinical diagnosis of common or plantar warts. Exclusion Criteria: - Pregnancy and lactation. - Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders. - Patients with inflamed lesions - Use of systemic or topical treatments during the last month before enrollment. - Individuals with history of allergic reactions to garlic or chlorhexidine - Patient with generalized dermatitis or allergic skin disorders

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: November 1, 2023

Completion date: December 1, 2025

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06077032