Non-Genital WartsNCT06077032
Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts
A study testing garlic extract (15%) solution, topical chlorhexidine (2%) solution and Saline in people with Non-Genital Warts, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-Genital Warts
- What is being tested?
- garlic extract (15%) solution, topical chlorhexidine (2%) solution and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with the clinical diagnosis of common or plantar warts.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Non-Genital Warts
- Being tested
- garlic extract (15%) solution, topical chlorhexidine (2%) solution, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
garlic extract (15%) solutionDrug
•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.
topical chlorhexidine (2%) solutionDrug
•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.
SalineDrug
Also called saline 0.9%
•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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
●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.
Measured: 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.
Measured: 6weeks up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Genital WartsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Nassar Abd El Hameed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077032
- Sponsor's protocol ID
- treatment of non genital warts
- Status last verified
- Oct 2023
- First submitted
- 9 Sep 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34890486Fernandez 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.
PubMed 34637092Brookes 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.
PubMed 33075450
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine and Garlic Extract as Potential Topical Virucidal Therapeutic Agents of Non-Genital Warts: A Prospective, Randomized, Controlled, Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06077032
- Acronym / sponsor ID
- treatment of non genital warts
- Conditions
- Non-Genital Warts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| garlic extract | Experimental | Drug: garlic extract (15%) solutionGarlic 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. |
| chlorhexidine | Experimental | Drug: topical chlorhexidine (2%) solutionChlorhexidine 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. |
| group3 | Placebo comparator | 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with the clinical diagnosis of common or plantar warts.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | garlic extract |
| 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. | Drug | chlorhexidine |
| SalineAlso: saline 0.9%•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 | group3 |
Primary outcome
●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.
●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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Background: PubMed 34890486Garcia-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.
- Background: PubMed 34637092Fernandez 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.
- Background: PubMed 33075450Brookes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing garlic extract (15%) solution, topical chlorhexidine (2%) solution and Saline in people with Non-Genital Warts, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaimaa N Ali, studient (00201060984990, shoo_shoo22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
●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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06077032, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.