Fungal Foot InfectionPhase 4WhitfieldZincNCT05901961
Effectiveness and Safety of Whitfield's Solution, Zinc Oxide Nanoparticles Solution or Combination for the Treatment of Fungal Feet Infection
A Phase 4 study testing Whitfield solution, Zinc oxide nanoparticles solution and Combined Whitfield and Zinc oxide nanoparticles solution in people with Fungal Foot Infection, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Foot Infection
- What is being tested?
- Whitfield solution, Zinc oxide nanoparticles solution and Combined Whitfield and Zinc oxide nanoparticles solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- 2 Jun 2023to 9 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
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
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.
Read the 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
- Being tested
- Whitfield solution, Zinc oxide nanoparticles solution, Combined Whitfield and Zinc oxide nanoparticles solution
- Keywords
- Whitfield, Zinc oxide nanoparticles, Fungal foot infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whitfield solutionDrug
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 solutionDrug
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 solutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Combined Whitfield and Zinc oxide nanoparticles solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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).
Measured: 4 weeks and 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start2 Jun 2023
- Primary completion9 Sep 2023
- Study completion9 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Fungal Foot InfectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Dermatological Society of Thailand
- Responsible party
- Sponsor
- Investigators
- Charussri Leeyaphan, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901961
- Sponsor's protocol ID
- Si 742/2020
- Acronym
- WhitfieldZinc
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8002148WILLIAMS 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.
PubMed 13240146Gondal 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.
PubMed 22571529Krol 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.
PubMed 28923702Mihai 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.
PubMed 31284587Vinardell 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.
PubMed 28336890Leite-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.
PubMed 27131753Tiwari 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.
PubMed 28477005Vander 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.
PubMed 127512622. 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.
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.
PubMed 39871011
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05901961
- Acronym / sponsor ID
- WhitfieldZinc / Si 742/2020
- Conditions
- Fungal Foot Infection
- Keywords
- Whitfield, Zinc oxide nanoparticles, Fungal foot infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Dermatological Society of Thailand
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 9 Sep 2023 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whitfield solution | Active comparator | Drug: Whitfield solutionThe 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 | Active comparator | Drug: Zinc oxide nanoparticles solutionThe 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 | Active comparator | Drug: Combined Whitfield and Zinc oxide nanoparticles solutionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whitfield solutionThe 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 solutionThe 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 solutionThe 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. | Drug | Combined Whitfield and Zinc oxide nanoparticles solution |
Primary outcome
Efficacy between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
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.
3 secondary outcomes
Safety between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection.
Time frame: 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.
Time frame: 4 weeks and 8 weeks
The diversity of microbiome in fungal foot infection patients before and 8 weeks after treatment
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 8002148Gooskens 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.
- Background: PubMed 13240146WILLIAMS 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.
- Background: PubMed 22571529Gondal 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.
- Background: PubMed 28923702Krol 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.
- Background: PubMed 31284587Mihai 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.
- Background: PubMed 28336890Vinardell 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.
- Background: PubMed 27131753Leite-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.
- Background: PubMed 28477005Tiwari 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 publication: PubMed 12751262Vander 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 publication2. 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.
- Derived from this study: PubMed 39871011Leeyaphan 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charussri Leeyaphan, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Whitfield solution, Zinc oxide nanoparticles solution and Combined Whitfield and Zinc oxide nanoparticles solution in people with Fungal Foot Infection, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy between Whitfield solution, zinc oxide nanoparticles particle, and a combination of Whitfield and Zinc oxide nanoparticles in treating fungal foot infection. (time frame: 4 weeks and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05901961, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.