Atmospheric pressure cold plasma treatment for moderate-to-severe athlete's foot

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

This will test whether atmospheric pressure cold plasma can clear moderate-to-severe tinea pedis (athlete's foot) in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shenyang Medical College (Academic / other)
• Locations: 1 site (Luoyang, Henan)
• Trial ID: NCT07056660 on ClinicalTrials.gov

What this trial studies

Adults with moderate-to-severe interdigital tinea pedis confirmed by KOH microscopy will receive active cold atmospheric plasma (CAP), a sham CAP procedure, or standard care to compare outcomes. Disease severity is defined by lesion scores for erythema, desquamation, and pruritus, and participants must meet predefined score thresholds to enroll. The study will measure fungal clearance, symptom improvement, recurrence, and safety over the treatment and follow-up period. Treatments are delivered to affected foot areas and safety monitoring will track local skin reactions and any adverse events.

Who should consider this trial

Good fit: Adults aged 18–70 with interdigital, non-hyperkeratotic moderate-to-severe tinea pedis confirmed by KOH and willing to use contraception if applicable are the intended candidates.

Not a fit: Patients with severe bacterial superinfection, major cardiac/hepatic/renal disease, diabetes, recent systemic antifungal or immunosuppressant use, or other interfering dermatologic conditions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, CAP could offer a non-drug, topical therapy that kills fungi and promotes healing, potentially reducing recurrences and the need for systemic antifungals.

How similar studies have performed: Preclinical and wound-healing research show strong antimicrobial effects of CAP, but clinical evidence for treating tinea pedis is limited and this application remains relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Luoyang, Henan

• The 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force — Luoyang, Henan, China (Recruiting)

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Yun-En Liu, MD

Conditions Tinea Pedis; Tinea pedis; Atmospheric pressure cold plasma