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

NCT05901961 | Completed Phase 4

• 1 other identifier: Si 742/2020
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Fungal Foot Infection

Keywords

Whitfield; Zinc oxide nanoparticles; Fungal foot infection

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks and 8 weeks

Secondary Outcomes (3)

• Safety 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

• 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.

  4 weeks and 8 weeks

• The diversity of microbiome in fungal foot infection patients before and 8 weeks after treatment

  8 weeks

Study Arms (3)

Whitfield solution

ACTIVE COMPARATOR

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.

Drug: Whitfield solution

Zinc oxide nanoparticles solution

ACTIVE COMPARATOR

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.

Drug: Zinc oxide nanoparticles solution

Combined Whitfield and Zinc oxide nanoparticles solution

ACTIVE COMPARATOR

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.

Drug: Combined Whitfield and Zinc oxide nanoparticles solution

Interventions

Whitfield solution 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.

Whitfield solution

Zinc oxide nanoparticles solution 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.

Zinc oxide nanoparticles solution

Combined Whitfield and Zinc oxide nanoparticles solution 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.

Combined Whitfield and Zinc oxide nanoparticles solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• Dermatological Society of Thailand: collaborator

Study Sites (1)

Department of Dermatology Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (11)

• 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.

  PMID: 8002148 BACKGROUND

• 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.

  PMID: 13240146 BACKGROUND

• 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.

  PMID: 22571529 BACKGROUND

• 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.

  PMID: 28923702 BACKGROUND

• 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.

  PMID: 31284587 BACKGROUND

• 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.

  PMID: 28336890 BACKGROUND

• 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.

  PMID: 27131753 BACKGROUND

• 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.

  PMID: 28477005 BACKGROUND

• 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.

  PMID: 12751262 RESULT

• 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.

  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.

  PMID: 39871011 DERIVED

Study Officials

• Charussri Leeyaphan, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: June 2, 2023
• Primary Completion: September 9, 2023
• Study Completion: September 9, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)