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

NCT06077032 | Unknown

• 1 other identifier: treatment of non genital warts
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim(s) of the Research:

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

Conditions

Non-Genital Warts

Outcome Measures

Primary Outcomes (2)

• ●Evaluate the efficacy and safety of topical chlorhexidine (2%) solution vs garlic extract (15%) solution in treating non-genital warts

  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

  will be evaluated at each visit.

  6weeks up to 3 month

Study Arms (3)

garlic extract

EXPERIMENTAL

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

chlorhexidine

EXPERIMENTAL

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

group3

PLACEBO COMPARATOR

•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

Interventions

garlic extract (15%) solution DRUG

•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.

garlic extract

topical chlorhexidine (2%) solution DRUG

•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.

chlorhexidine

Saline DRUG

•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).

Also known as: saline 0.9%

group3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the clinical diagnosis of common or plantar warts.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 34890486 BACKGROUND

• 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.

  PMID: 34637092 BACKGROUND

• 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.

  PMID: 33075450 BACKGROUND

MeSH Terms

Interventions

Solutions; Chlorhexidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Biguanides; Guanidines; Amidines; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Shaimaa N Ali, studient

CONTACT

00201060984990; shoo_shoo22@yahoo.com

Eman R Mohamed, Prof

CONTACT

01005298992; e_riad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assuit seed street

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: October 11, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 16, 2023

Record last verified: 2023-10