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

Primary Purpose

Fungal Foot Infection

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Whitfield solution
Zinc oxide nanoparticles solution
Combined Whitfield and Zinc oxide nanoparticles solution
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Foot Infection focused on measuring Whitfield, Zinc oxide nanoparticles, Fungal foot infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Whitfield solution

    Zinc oxide nanoparticles solution

    Combined Whitfield and Zinc oxide nanoparticles solution

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    Efficacy between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
    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.

    Secondary Outcome Measures

    Safety between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
    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.
    Comparing patients' satisfaction between using Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
    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).
    The diversity of microbiome in fungal foot infection patients before and 8 weeks after treatment
    The composition of the microbiome in patients with fungal foot infections will be evaluated before and 8 weeks after treatment.

    Full Information

    First Posted
    June 5, 2023
    Last Updated
    June 15, 2023
    Sponsor
    Mahidol University
    Collaborators
    Dermatological Society of Thailand
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05901961
    Brief Title
    Effectiveness and Safety of Whitfield's Solution, Zinc Oxide Nanoparticles Solution or Combination for the Treatment of Fungal Feet Infection
    Acronym
    WhitfieldZinc
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University
    Collaborators
    Dermatological Society of Thailand

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fungal Foot Infection
    Keywords
    Whitfield, Zinc oxide nanoparticles, Fungal foot infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    84 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Whitfield solution
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Zinc oxide nanoparticles solution
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Combined Whitfield and Zinc oxide nanoparticles solution
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Whitfield solution
    Intervention Description
    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
    Intervention Name(s)
    Zinc oxide nanoparticles solution
    Intervention Description
    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
    Intervention Name(s)
    Combined Whitfield and Zinc oxide nanoparticles solution
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Efficacy between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Safety between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
    Description
    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
    Title
    Comparing patients' satisfaction between using Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
    Description
    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
    4 weeks and 8 weeks
    Title
    The diversity of microbiome in fungal foot infection patients before and 8 weeks after treatment
    Description
    The composition of the microbiome in patients with fungal foot infections will be evaluated before and 8 weeks after treatment.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Charussri Leeyaphan, MD
    Phone
    +6624194333
    Email
    charussrilee@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sumanas Bunyaratavej, MD
    Phone
    +6624194333
    Email
    consultskin@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charussri Leeyaphan, MD
    Organizational Affiliation
    Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    8002148
    Citation
    Gooskens V, Ponnighaus JM, Clayton Y, Mkandawire P, Sterne JA. Treatment of superficial mycoses in the tropics: Whitfield's ointment versus clotrimazole. Int J Dermatol. 1994 Oct;33(10):738-42. doi: 10.1111/j.1365-4362.1994.tb01524.x.
    Results Reference
    background
    PubMed Identifier
    13240146
    Citation
    WILLIAMS DI. The Whitfield tradition of therapy. Br Med J. 1955 Aug 20;2(4937):453-5. doi: 10.1136/bmj.2.4937.453. No abstract available.
    Results Reference
    background
    PubMed Identifier
    22571529
    Citation
    Gondal MA, Alzahrani AJ, Randhawa MA, Siddiqui MN. Morphology and antifungal effect of nano-ZnO and nano-Pd-doped nano-ZnO against Aspergillus and Candida. J Environ Sci Health A Tox Hazard Subst Environ Eng. 2012;47(10):1413-8. doi: 10.1080/10934529.2012.672384.
    Results Reference
    background
    PubMed Identifier
    28923702
    Citation
    Krol A, Pomastowski P, Rafinska K, Railean-Plugaru V, Buszewski B. Zinc oxide nanoparticles: Synthesis, antiseptic activity and toxicity mechanism. Adv Colloid Interface Sci. 2017 Nov;249:37-52. doi: 10.1016/j.cis.2017.07.033. Epub 2017 Aug 26. Erratum In: Adv Colloid Interface Sci. 2018 Apr;254:100.
    Results Reference
    background
    PubMed Identifier
    31284587
    Citation
    Mihai MM, Dima MB, Dima B, Holban AM. Nanomaterials for Wound Healing and Infection Control. Materials (Basel). 2019 Jul 6;12(13):2176. doi: 10.3390/ma12132176.
    Results Reference
    background
    PubMed Identifier
    28336890
    Citation
    Vinardell MP, Llanas H, Marics L, Mitjans M. In Vitro Comparative Skin Irritation Induced by Nano and Non-Nano Zinc Oxide. Nanomaterials (Basel). 2017 Mar 4;7(3):56. doi: 10.3390/nano7030056.
    Results Reference
    background
    PubMed Identifier
    27131753
    Citation
    Leite-Silva VR, Sanchez WY, Studier H, Liu DC, Mohammed YH, Holmes AM, Ryan EM, Haridass IN, Chandrasekaran NC, Becker W, Grice JE, Benson HA, Roberts MS. Human skin penetration and local effects of topical nano zinc oxide after occlusion and barrier impairment. Eur J Pharm Biopharm. 2016 Jul;104:140-7. doi: 10.1016/j.ejpb.2016.04.022. Epub 2016 Apr 27.
    Results Reference
    background
    PubMed Identifier
    28477005
    Citation
    Tiwari N, Pandit R, Gaikwad S, Gade A, Rai M. Biosynthesis of zinc oxide nanoparticles by petals extract of Rosa indica L., its formulation as nail paint and evaluation of antifungal activity against fungi causing onychomycosis. IET Nanobiotechnol. 2017 Mar;11(2):205-211. doi: 10.1049/iet-nbt.2016.0003.
    Results Reference
    background
    PubMed Identifier
    12751262
    Citation
    Vander Straten MR, Hossain MA, Ghannoum MA. Cutaneous infections dermatophytosis, onychomycosis, and tinea versicolor. Infect Dis Clin North Am. 2003 Mar;17(1):87-112. doi: 10.1016/s0891-5520(02)00065-x.
    Results Reference
    result
    Citation
    2. Nigam PK, Saleh D. Tinea Pedis. [Updated 2020 May 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470421/. Accessed August 22, 2020.
    Results Reference
    result

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