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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06077032

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Aim(s) of the Research:

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

Condition or Disease	Intervention/Treatment	Phase
Non-Genital Warts	Drug: garlic extract (15%) solution Drug: topical chlorhexidine (2%) solution Drug: Saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Shaimaa Nassar Abd El Hameed Ali, Assuit seed street, Assiut University

ClinicalTrials.gov Identifier:

NCT06077032

Other Study ID Numbers:

treatment of non genital warts

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Warts

Chlorhexidine

Pharmaceutical Solutions

Study Results

No Results Posted as of Oct 16, 2023