Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
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
Shenyang Medical College
220 participants
Jul 25, 2025
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria5
- 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.
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Interventions
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.
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.
The group will receive standard care according to current clinical guidelines
Locations(1)
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NCT07056660