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

October 13, 2023 updated by: Shaimaa Nassar Abd El Hameed Ali, Assiut University

Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts: A Prospective, Randomized, Controlled, Blinded Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: garlic extract

Garlic will be collected from Medicinal Plant station, Pharmacognosy Department, Faculty of Pharmacy, Assiut University.

The fresh garlic bulbs will be crushed. Extraction will be done using maceration method with Ethanol for 24 h at room temperature.

Freeze-drying method will be used to remove solvent and give dry powder. Dry powder will be mixed with isopropyl alcohol in a ultrasonic bath to solve thoroughly.

The soluble garlic extract will be added to a mixture of Polyethylene Glycol. The topical garlic formulation will be prepared for each time for two weeks-use and will be kept in dark glass containers in refrigerator till prescription.

•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.
Drug: garlic extract (15%) solution
•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.
Experimental: chlorhexidine

Chlorhexidine 4% (Laries, manufactured by: Smartec Egypt) will be diluted with equal amount of distilled water to obtain a concentration of 2%.

•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.
Drug: topical chlorhexidine (2%) solution
•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.
Placebo Comparator: group3
•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).
Drug: Saline
•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).
Other Names:
  • saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
●Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts
Time Frame: 6weeks up to 3 month
will be evaluated by changing in the size (using ruler) and the number of lesions.
6weeks up to 3 month
●Side effects (systemic of local) as burning, itching, erythema, pigmentary changes, ulceration, and scarring
Time Frame: 6weeks up to 3 month
will be evaluated at each visit.
6weeks up to 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 9, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • treatment of non genital warts

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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