Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
NCT Number: NCT05901961
This study aimed to study the efficacy of Whitfield's solution, zinc oxide nanoparticles solution, and the combination of Whitfield's and zinc oxide nanoparticles solution in treating fungal feet infection.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Bangkoknoi, Bangkok, 10700, Thailand
Fungal foot infections are a common problem in medical practice, particularly among the elderly population. These infections can present in various ways, often characterized by dry and flaky skin on the feet. While the symptoms of fungal foot infections are generally gradual or even asymptomatic, they can lead to more severe complications, such as bacterial infections.
Topical antifungal drugs are primarily used for treating fungal foot infections, especially when the infection is localized and not present in other areas of the body. These medications have proven to be effective against dermatophyte fungal foot infections. However, in Thailand, fungal foot infections are frequently caused by non-dermatophyte species, which typically do not respond well to antifungal drugs. In such cases, topical peeling ointments like Whitfield Ointment are employed, as they offer favorable treatment outcomes for both dermatophyte and non-dermatophyte fungal foot infections. One drawback of Whitfield Ointment is its sticky consistency, which can adhere to surfaces, leading to irregular medication use by patients. At Siriraj Hospital, a Whitfield solution has been developed, although its therapeutic efficacy has yet to be studied. Nevertheless, based on its ingredients, it is expected to be similar to the ointment formulation.
Zinc oxide nanoparticles have exhibited activity against various bacteria and fungi, while remaining safe for human cells. They do not cause skin irritation and are not absorbed into the epidermis.
Based on a literature review, the use of zinc oxide nanoparticle solution and Whitfield solution for treating fungal foot infections has not been investigated. Therefore, our objective is to evaluate the effectiveness of zinc oxide nanoparticle solution alone, Whitfield solution alone, and a combination of Whitfield solution and zinc oxide nanoparticles in the treatment of fungal foot infections. Additionally, we aim to examine any potential side effects and assess user satisfaction with these treatments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patient will receive 60 mL of Whitfield solution. They will be instructed to apply 0.5 mL of the solution to the lesion twice daily for a consecutive period of 8 weeks.
The patient will receive 60 mL of 1% Zinc oxide nanoparticles solution. They will be instructed to apply 0.5 mL of the solution to the lesion twice daily for a consecutive period of 8 weeks.
The patient will receive 60 mL of combined Whitfield and Zinc oxide nanoparticles solution. They will be instructed to apply 0.5 mL of the solution to the lesion twice daily for a consecutive period of 8 weeks.
Time frame: 4 weeks and 8 weeks
The efficacy of Whitfield solution, zinc oxide nanoparticles, and a combination of Whitfield solution and zinc oxide nanoparticles in treating fungal foot infections will be evaluated by comparing the proportion of patients with negative results from the KOH test for fungal infection at both 4 weeks and 8 weeks.
Time frame: 4 weeks and 8 weeks
The safety of Whitfield solution, zinc oxide nanoparticles, and a combination of Whitfield solution and zinc oxide nanoparticles in treating fungal foot infections will be evaluated by comparing the incidence of adverse effects resulting from each medication in each group at both 4 weeks and 8 weeks.
Time frame: 4 weeks and 8 weeks
The satisfaction of patients using Whitfield solution, zinc oxide nanoparticles, and a combination of Whitfield solution and zinc oxide nanoparticles in treating fungal foot infections will be evaluated at both 4 weeks and 8 weeks by asking the patients to rate their satisfaction score on the 5-point Likert scale from 0 to 4 (Higher scores mean a a better outcome).
Time frame: 8 weeks
The composition of the microbiome in patients with fungal foot infections will be evaluated before and 8 weeks after treatment.
Mahidol University
Other
A Study of Effectiveness and Safety of Whitfield's Solution, Zinc Oxide Nanoparticles Solution and the Combination of Whitfield's and Zinc Oxide Nanoparticles Solution for the Treatment of Fungal Feet Infection
Acronym: WhitfieldZinc
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.