Clinical trial NCT06077032: Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts
Official title: Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts: A Prospective, Randomized, Controlled, Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Genital Warts
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: ●Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts
timeFrame: 6weeks up to 3 month
measure: ●Side effects (systemic of local) as burning, itching, erythema, pigmentary changes, ulceration, and scarring
timeFrame: 6weeks up to 3 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Garcia-Oreja S, Alvaro-Afonso FJ, Sevillano-Fernandez D, Tardaguila-Garcia A, Lopez-Moral M, Lazaro-Martinez JL. A non-invasive method for diagnosing plantar warts caused by human papillomavirus (HPV). J Med Virol. 2022 Jun;94(6):2897-2901. doi: 10.1002/jmv.27514. Epub 2021 Dec 15.
citation: Fernandez MDS, Guedes MIF, Langa GPJ, Rosing CK, Cavagni J, Muniz FWMG. Virucidal efficacy of chlorhexidine: a systematic review. Odontology. 2022 Apr;110(2):376-392. doi: 10.1007/s10266-021-00660-x. Epub 2021 Oct 12.
citation: Brookes ZLS, Bescos R, Belfield LA, Ali K, Roberts A. Current uses of chlorhexidine for management of oral disease: a narrative review. J Dent. 2020 Dec;103:103497. doi: 10.1016/j.jdent.2020.103497. Epub 2020 Oct 17.