Effectiveness and Safety of Whitfield's Solution, Zinc Oxide Nanoparticles Solution or Combination for the Treatment of Fungal Feet Infection

NCT ID: NCT05901961

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-02
• Study Completion Date: 2023-09-09

Brief Summary

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.

Detailed Description

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.

Conditions

Fungal Foot Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Whitfield solution

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.

Group Type: ACTIVE_COMPARATOR

Whitfield solution

Intervention Type: DRUG

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.

Zinc oxide nanoparticles solution

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.

Group Type: ACTIVE_COMPARATOR

Zinc oxide nanoparticles solution

Intervention Type: DRUG

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.

Combined Whitfield and Zinc oxide nanoparticles solution

The patient will receive 60 mL of combined Whitfield and 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.

Group Type: ACTIVE_COMPARATOR

Combined Whitfield and Zinc oxide nanoparticles solution

Intervention Type: DRUG

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.

Interventions

Whitfield solution

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.

Intervention Type: DRUG

Zinc oxide nanoparticles solution

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.

Intervention Type: DRUG

Combined Whitfield and Zinc oxide nanoparticles solution

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patient was diagnosed with a fungal foot infection based on the clinical presentation and a positive result from a microscopic examination for fungus.
• The patient must not have received any prior antifungal therapy, including topical, oral, or intravenous routes, within 36 weeks prior to recruitment.

Exclusion Criteria

• Patients with conditions other than fungal foot infections, such as bacterial infections or inflammation of the skin on the foot
• Patients with other fungal diseases that require treatment with systemic antifungals, such as onychomycosis or tinea capitis
• Patients who are currently taking immunosuppressants or are immunocompromised.
• Patients who have difficulty applying the medication by themselves.
• Patients who have been treated for fungal foot infection using methods that are not included in the research protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dermatological Society of Thailand

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charussri Leeyaphan, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Department of Dermatology Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Countries

Thailand

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Reference Type: RESULT

Leeyaphan C, Punnakitikashem P, Suiwongsa B, Komesmuneeborirak P, Chongtrakool P, Kulthanachairojana N, Limphoka P, Hutachoke T, Saengthong-Aram P, Kobkurkul P, Wongdama S, Pongkittilar B, Matthapan L, Panyawong C, Prasong W, Plengpanich A, Kunwong N, Rodponthukwaji K, Bunyaratavej S. Efficacy, Safety, and Cost-effectiveness of Zinc Oxide Nanoparticles in Whitfield's Spirit Solution for Treating Superficial Fungal Foot Infections: A Randomized Controlled Trial. Dermatol Ther (Heidelb). 2025 Feb;15(2):351-365. doi: 10.1007/s13555-025-01340-2. Epub 2025 Jan 27.

Reference Type: DERIVED

PMID: 39871011 (View on PubMed)

Other Identifiers

Si 742/2020

Identifier Type: -

Identifier Source: org_study_id