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

ConditionTinea Pedis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorShenyang Medical College

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Active CAP therapy
Device
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.
Sham CAP therapy
Device
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.
standard care
Other intervention
The group will receive standard care according to current clinical guidelines

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: CAP groupActive comparator 2 interventions

Group B: Sham groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Change in lesion area

Assessments are conducted daily for the first five days (V1-V5), and every two days thereafter (V6-V13).

Time frame

Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13)

Secondary outcomes

Time to 10% reduction in lesion area

Time frame

Assessment time points: Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).

Change in quality of life as measured by the EQ-5D questionnaire

Time frame

Baseline and at the last visit during the treatment period (V1, V13).

Change in quality of life as measured by the SF-12 questionnaire

Time frame

Baseline and at the last visit during the treatment period (V1, V13).

Incidence of skin irritation

Time frame

Baseline (V0) and at each visit within 20 ± 1 days after randomization (V1-V13).

Other outcomes

Change in quality of life as measured by the EQ-5D questionnaire

Time frame

Baseline and at follow-up visits at 180 ± 15 days and 360 ± 20 days after randomization (V1, V14, V15).

Change in quality of life as measured by the SF-12 questionnaire

Time frame

Baseline and at follow-up visits at 180 ± 15 days and 360 ± 20 days after randomization (V1, V14, V15).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenyang Medical College

Lead sponsor

Tsinghua University

Collaborator

Source ClinicalTrials.gov

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