Tinea PedisNCT07056660
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
A study testing Active CAP therapy in people with Tinea Pedis, run by Shenyang Medical College at 1 site in China.
Trial summary
Tinea pedis (athlete's foot) is a common and highly contagious fungal infection of the feet. Moderate-to-severe cases present with extensive skin lesions, severe symptoms, frequent recurrences, and increased risk of complications, often proving refractory to conventional topical therapies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Active CAP therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2025to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years, irrespective of sex.
- Clinical diagnosis of interdigital tinea pedis (non-hyperkeratotic type), with or without extension to other areas, of moderate to severe intensity, defined as follows: target lesion(s) will have an erythema score of ≥2 and either a desquamation or pruritus score of ≥2, with a total score ≥4 (using a 0-3 scale for each item).
- Positive direct potassium hydroxide (KOH) microscopic examination for dermatophytes.
- Women of childbearing potential will agree to use effective contraception throughout the study period.
- Written informed consent will be obtained prior to enrollment.
Who cannot join
- Severe bacterial infection or other dermatological conditions that may interfere with study assessments.
- Serious cardiac, hepatic, or renal diseases, diabetes mellitus, or major psychiatric disorders.
- Systemic corticosteroid or immunosuppressant use within the past 3 months.
- Systemic antifungal agents within the past 2 months or topical antifungal agents within the past 2 weeks.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force
Luoyang, Henan
Xue Wen, MM, Ly150rlzyb@163.com
About this study
Official title: Efficacy and Safety of Atmospheric Pressure Cold Plasma in the Treatment of Moderate-to-severe Tinea Pedis: a Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Clinical Trial
Tinea pedis (athlete's foot) is a common and highly contagious fungal infection of the feet. Moderate-to-severe cases present with extensive skin lesions, severe symptoms, frequent recurrences, and increased risk of complications, often proving refractory to conventional topical therapies. Anatomical niches, poor drug penetration, and antifungal resistance make effective management challenging and negatively impact patients' quality of life.
Current treatments, including topical and systemic antifungals or physical modalities, are often limited by incomplete efficacy, complexity, or poor adherence. Therefore, more effective and practical treatment options are urgently needed.
Atmospheric pressure cold plasma (CAP) is an innovative technology that generates reactive species capable of targeting pathogens while preserving normal tissue. CAP has demonstrated strong antimicrobial effects and promotes wound healing in biomedical research. This study will evaluate the efficacy and safety of CAP in treating moderate-to-severe tinea pedis, aiming to address unmet clinical needs and support future clinical application.
Read the detailed description
Tinea pedis, commonly known as athlete's foot, is a highly contagious dermatophytic infection of the feet, characterized by erythema, desquamation, vesicles, and sometimes thickening or fissuring of the skin. It remains one of the most prevalent skin diseases worldwide, especially in hot and humid environments, which favor fungal growth and transmission. Typical clinical manifestations include blistering, scaling, and itching between the toes, on the heels, and the lateral aspects of the foot; in severe cases, patients may experience maceration, exudation, and secondary bacterial infections.
Moderate-to-severe tinea pedis is associated with extensive skin involvement, more intense symptoms (such as severe pruritus, pain, and functional impairment), frequent recurrences, and an increased risk of complications including cellulitis and chronic wounds. These forms of the disease are not only more refractory to conventional topical therapies, but also have a significant impact on patients' quality of life and daily functioning. Persistent or extensive lesions are more likely to harbor residual fungi in anatomical niches (e.g., toe webs, heel fissures), leading to repeated treatment failures and contributing to transmission within households and the wider community. Therefore, improving the efficacy of fungal inactivation and reducing recurrence rates in moderate-to-severe tinea pedis is a key unmet need in dermatology.
Over the years, multiple approaches have been explored for superficial fungal eradication, including preventive measures, physical therapies, and chemical agents. However, current treatments face several limitations: (1) the complex anatomical structure and irregular surface of the foot make it difficult for topical agents or sterilization procedures to penetrate all affected areas, often leaving residual fungi; (2) dermatophytes have substantial survival capacity and may develop resistance, making mild or insufficient therapies less effective for complete eradication; (3) many existing treatment modalities are cumbersome, require complex procedures, or lack flexibility, limiting their widespread use and patient adherence. As a result, achieving both effective fungal eradication and practical, patient-friendly treatment options remains an important clinical challenge, especially for moderate-to-severe cases.
Atmospheric pressure cold plasma (CAP) represents an innovative fourth-state physical technology, capable of generating a high density of energetic electrons, ions, excited atoms, and reactive species (including ROS and RNS) at near-room temperature. This technology has been widely adopted for material processing, environmental protection, new energy applications, and increasingly, for biomedical purposes. In medical research, CAP-generated reactive agents, ultraviolet irradiation, and thermal effects have been shown to disrupt microbial cell structures, induce apoptosis, and promote tissue regeneration by stimulating growth factor expression and enhancing wound healing processes. Importantly, CAP offers selective cytotoxicity, enabling targeted inactivation of pathogenic microorganisms while preserving normal tissue viability through adjustable plasma parameters.
Given its potent antimicrobial effects, safety profile, and unique physical-chemical mechanisms, CAP is a highly promising candidate for the treatment of recalcitrant cutaneous infections, such as moderate-to-severe tinea pedis. Applying CAP to the management of tinea pedis could potentially address the unmet needs of deeper fungal eradication, reduced recurrence, and improved patient outcomes, particularly in those with more extensive, symptomatic, or difficult-to-treat disease.
Based on this rationale, the present study will evaluate the efficacy and safety of CAP in the treatment of moderate-to-severe tinea pedis, providing important supporting evidence for larger-scale clinical applications in the future.
- Conditions
- Tinea Pedis
- Being tested
- Active CAP therapy, Sham CAP therapy, standard care
- Keywords
- Tinea pedis, Atmospheric pressure cold plasma
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active CAP therapyDevice
The CAP group will additionally undergo atmospheric pressure cold plasma (CAP) treatment (plasma-activated gas form, CAP-Activated Gas; patent number: ZL202110209052.X, provided by Xi'an Jiaotong University), once daily for the first five days and every other day thereafter, for a total of 13 sessions. Each session will involve enclosing the target area in a treatment bag sealed with medical adhesive tape; plasma-activated gas rich in ozone (O₃) will be delivered and recirculated for 20 minutes, followed by plasma-activated gas rich in nitric oxide (NO) for an additional 5 minutes, in strict accordance with the standard operating procedures provided by the manufacturer.
Sham CAP therapyDevice
In the placebo group, the electric field for plasma generation will remain off, so no plasma will be produced; only operational sounds will be simulated to maintain procedural blinding.
standard careOther
The group will receive standard care according to current clinical guidelines
| Study group | Role | What they receive |
|---|---|---|
| CAP group | Active comparator | Not described Receives: Device: Active CAP therapy; Other: standard care |
| Sham group | Placebo comparator | Not described Receives: Device: Sham CAP therapy; Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion area
Assessments are conducted daily for the first five days (V1-V5), and every two days thereafter (V6-V13).
Measured: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13)
Secondary outcomes (5)
Time to 10% reduction in lesion area
Measured: Assessment time points: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).
Change in quality of life as measured by the EQ-5D questionnaire
Measured: Baseline and at the last visit during the treatment period (V1, V13).
Change in quality of life as measured by the SF-12 questionnaire
Measured: Baseline and at the last visit during the treatment period (V1, V13).
Incidence of skin irritation
Measured: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).
Incidence of local burning sensation
Measured: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start25 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion20 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Principal investigator, Lin Tao, Shenyang Medical College
- Investigators
- Yun-En Liu, MD, Study chair, Shenyang Medical CollegeLin Tao, MM, Principal investigator, Shenyang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056660
- Sponsor's protocol ID
- 630pedis
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Atmospheric Pressure Cold Plasma in the Treatment of Moderate-to-severe Tinea Pedis: a Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07056660
- Acronym / sponsor ID
- 630pedis
- Conditions
- Tinea Pedis
- Keywords
- Tinea pedis, Atmospheric pressure cold plasma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shenyang Medical CollegeUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 20 Aug 2026 (estimated)
- First posted
- 9 Jul 2025 (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.
Tinea pedis (athlete's foot) is a common and highly contagious fungal infection of the feet. Moderate-to-severe cases present with extensive skin lesions, severe symptoms, frequent recurrences, and increased risk of complications, often proving refractory to conventional topical therapies. Anatomical niches, poor drug penetration, and antifungal resistance make effective management challenging and negatively impact patients' quality of life.
Current treatments, including topical and systemic antifungals or physical modalities, are often limited by incomplete efficacy, complexity, or poor adherence. Therefore, more effective and practical treatment options are urgently needed.
Atmospheric pressure cold plasma (CAP) is an innovative technology that generates reactive species capable of targeting pathogens while preserving normal tissue. CAP has demonstrated strong antimicrobial effects and promotes wound healing in biomedical research. This study will evaluate the efficacy and safety of CAP in treating moderate-to-severe tinea pedis, aiming to address unmet clinical needs and support future clinical application.
Detailed description
Tinea pedis, commonly known as athlete's foot, is a highly contagious dermatophytic infection of the feet, characterized by erythema, desquamation, vesicles, and sometimes thickening or fissuring of the skin. It remains one of the most prevalent skin diseases worldwide, especially in hot and humid environments, which favor fungal growth and transmission. Typical clinical manifestations include blistering, scaling, and itching between the toes, on the heels, and the lateral aspects of the foot; in severe cases, patients may experience maceration, exudation, and secondary bacterial infections.
Moderate-to-severe tinea pedis is associated with extensive skin involvement, more intense symptoms (such as severe pruritus, pain, and functional impairment), frequent recurrences, and an increased risk of complications including cellulitis and chronic wounds. These forms of the disease are not only more refractory to conventional topical therapies, but also have a significant impact on patients' quality of life and daily functioning. Persistent or extensive lesions are more likely to harbor residual fungi in anatomical niches (e.g., toe webs, heel fissures), leading to repeated treatment failures and contributing to transmission within households and the wider community. Therefore, improving the efficacy of fungal inactivation and reducing recurrence rates in moderate-to-severe tinea pedis is a key unmet need in dermatology.
Over the years, multiple approaches have been explored for superficial fungal eradication, including preventive measures, physical therapies, and chemical agents. However, current treatments face several limitations: (1) the complex anatomical structure and irregular surface of the foot make it difficult for topical agents or sterilization procedures to penetrate all affected areas, often leaving residual fungi; (2) dermatophytes have substantial survival capacity and may develop resistance, making mild or insufficient therapies less effective for complete eradication; (3) many existing treatment modalities are cumbersome, require complex procedures, or lack flexibility, limiting their widespread use and patient adherence. As a result, achieving both effective fungal eradication and practical, patient-friendly treatment options remains an important clinical challenge, especially for moderate-to-severe cases.
Atmospheric pressure cold plasma (CAP) represents an innovative fourth-state physical technology, capable of generating a high density of energetic electrons, ions, excited atoms, and reactive species (including ROS and RNS) at near-room temperature. This technology has been widely adopted for material processing, environmental protection, new energy applications, and increasingly, for biomedical purposes. In medical research, CAP-generated reactive agents, ultraviolet irradiation, and thermal effects have been shown to disrupt microbial cell structures, induce apoptosis, and promote tissue regeneration by stimulating growth factor expression and enhancing wound healing processes. Importantly, CAP offers selective cytotoxicity, enabling targeted inactivation of pathogenic microorganisms while preserving normal tissue viability through adjustable plasma parameters.
Given its potent antimicrobial effects, safety profile, and unique physical-chemical mechanisms, CAP is a highly promising candidate for the treatment of recalcitrant cutaneous infections, such as moderate-to-severe tinea pedis. Applying CAP to the management of tinea pedis could potentially address the unmet needs of deeper fungal eradication, reduced recurrence, and improved patient outcomes, particularly in those with more extensive, symptomatic, or difficult-to-treat disease.
Based on this rationale, the present study will evaluate the efficacy and safety of CAP in the treatment of moderate-to-severe tinea pedis, providing important supporting evidence for larger-scale clinical applications in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAP group | Active comparator | Device: Active CAP therapy, Other: standard care |
| Sham group | Placebo comparator | Device: Sham CAP therapy, Other: standard care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years, irrespective of sex.
- Clinical diagnosis of interdigital tinea pedis (non-hyperkeratotic type), with or without extension to other areas, of moderate to severe intensity, defined as follows: target lesion(s) will have an erythema score of ≥2 and either a desquamation or pruritus score of ≥2, with a total score ≥4 (using a 0-3 scale for each item).
- Positive direct potassium hydroxide (KOH) microscopic examination for dermatophytes.
- Women of childbearing potential will agree to use effective contraception throughout the study period.
- Written informed consent will be obtained prior to enrollment.
Key exclusion criteria (5 listed)
- Severe bacterial infection or other dermatological conditions that may interfere with study assessments.
- Serious cardiac, hepatic, or renal diseases, diabetes mellitus, or major psychiatric disorders.
- Systemic corticosteroid or immunosuppressant use within the past 3 months.
- Systemic antifungal agents within the past 2 months or topical antifungal agents within the past 2 weeks.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Active CAP therapyThe CAP group will additionally undergo atmospheric pressure cold plasma (CAP) treatment (plasma-activated gas form, CAP-Activated Gas; patent number: ZL202110209052.X, provided by Xi'an Jiaotong University), once daily for the first five days and every other day thereafter, for a total of 13 sessions. Each session will involve enclosing the target area in a treatment bag sealed with medical adhesive tape; plasma-activated gas rich in ozone (O₃) will be delivered and recirculated for 20 minutes, followed by plasma-activated gas rich in nitric oxide (NO) for an additional 5 minutes, in strict accordance with the standard operating procedures provided by the manufacturer. | Device | CAP group |
| Sham CAP therapyIn the placebo group, the electric field for plasma generation will remain off, so no plasma will be produced; only operational sounds will be simulated to maintain procedural blinding. | Device | Sham group |
| standard careThe group will receive standard care according to current clinical guidelines | Other | CAP group, Sham group |
Primary outcome
Change in lesion area
Time frame: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13)
Assessments are conducted daily for the first five days (V1-V5), and every two days thereafter (V6-V13).
5 secondary outcomes
Time to 10% reduction in lesion area
Time frame: Assessment time points: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).
Change in quality of life as measured by the EQ-5D questionnaire
Time frame: Baseline and at the last visit during the treatment period (V1, V13).
Change in quality of life as measured by the SF-12 questionnaire
Time frame: Baseline and at the last visit during the treatment period (V1, V13).
Incidence of skin irritation
Time frame: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).
Incidence of local burning sensation
Time frame: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Yun-En Liu, MD study chair
Shenyang Medical College
Lin Tao, MM principal investigator
Shenyang Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active CAP therapy in people with Tinea Pedis, run by Shenyang Medical College at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun-En Liu, MD (86-24-62215130, lye9901@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion area (time frame: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.