About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Active CAP therapy
- Sham CAP therapy
- standard care
Treatment groups
Sponsors and collaborators
Shenyang Medical College
Lead sponsor
Tsinghua University
Collaborator