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

NCT07056660 | Recruiting DMC

• 1 other identifier: 630pedis
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tinea pedis; Atmospheric pressure cold plasma

Outcome Measures

Primary Outcomes (1)

• Change in lesion area

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

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

Secondary Outcomes (5)

• Time to 10% reduction in lesion area

  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

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

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

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

• Incidence of skin irritation

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

• Incidence of local burning sensation

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

Other Outcomes (2)

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

  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

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

Study Arms (2)

CAP group

ACTIVE COMPARATOR

Device: Active CAP therapy; Other: standard care

Sham group

PLACEBO COMPARATOR

Device: Sham CAP therapy; Other: standard care

Interventions

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.

CAP group

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.

Sham group

standard care OTHER

The group will receive standard care according to current clinical guidelines

CAP group; Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tsinghua University: collaborator
• Shenyang Medical College: lead

Study Sites (1)

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

Luoyang, Henan, China

RECRUITING

MeSH Terms

Conditions

Tinea Pedis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yun-En Liu, MD

  Shenyang Medical College

  STUDY CHAIR

• Lin Tao, MM

  Shenyang Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-En Liu, MD

CONTACT

86-24-62215130; lye9901@163.com

Lin Tao, MM

CONTACT

86-18802401698; 1939908868@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MM

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)