Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis

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.

Conditions

• Tinea Pedis

Interventions

DEVICE

Active CAP therapy

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.

DEVICE

Sham CAP therapy

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.

OTHER

standard care

The group will receive standard care according to current clinical guidelines

Sponsors & Collaborators

• Tsinghua University

  collaborator OTHER

• Shenyang Medical College

  lead OTHER

Principal Investigators

• Yun-En Liu, MD · Shenyang Medical College

• Lin Tao, MM · Shenyang Medical College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-25

Primary Completion

2026-07-15

Completion

2026-08-20

Countries

• China

Study Locations