Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07056660

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

Led by Shenyang Medical College · Updated on 2026-01-02

220

Participants Needed

1

Research Sites

55 weeks

Total Duration

On this page

Sponsors

S

Shenyang Medical College

Lead Sponsor

T

Tsinghua University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 70 years, any sex
  • Clinical diagnosis of moderate to severe interdigital tinea pedis (non-hyperkeratotic type) with target lesion erythema score ≥2 and desquamation or pruritus score ≥2, total score ≥4 on a 0-3 scale
  • Positive potassium hydroxide (KOH) microscopic test for dermatophytes
  • Women of childbearing potential agree to use effective contraception throughout the study
  • Provide written informed consent prior to enrollment
Not Eligible

You will not qualify if you...

  • Severe bacterial infection or other skin conditions interfering with assessments
  • Serious heart, liver, or kidney disease, diabetes, or major psychiatric disorders
  • Use of systemic corticosteroids or immunosuppressants in past 3 months
  • Use of systemic antifungal agents within past 2 months or topical antifungal agents within past 2 weeks
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

The 989th Hospital of Chinese People's Liberation Army Joint Logistic Support Force

Luoyang, Henan, China

Actively Recruiting

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Research Team

Y

Yun-En Liu, MD

CONTACT

L

Lin Tao, MM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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