Clinical trial
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
Name
Si 742/2020
Description
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.
Trial arms
Trial start
2023-06-02
Estimated PCD
2023-09-09
Trial end
2023-09-09
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Whitfield solution
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.
Arms:
Zinc oxide nanoparticles solution
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.
Arms:
Combined Whitfield and Zinc oxide nanoparticles solution
Size
84
Primary endpoint
Efficacy between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
4 weeks and 8 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}
Updated at
2024-03-27
1 organization
3 products
1 indication
Organization
Mahidol UniversityProduct
WhitfieldIndication
Fungal Foot InfectionProduct
Zinc oxide nanoparticles