Treatment of nail fungus using infrared therapy
A Multicenter Clinical Trial of Infrared Bioeffect System for the Treatment of Onychomycosis
This study is testing if using infrared heat therapy can help people with nail fungus get rid of the infection and improve their nails over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Hospital of China Medical University Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06036654 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of mild local hyperthermia using an infrared thermotherapy instrument for treating onychomycosis, a common nail infection. Participants with at least two affected nails will receive treatment, and the outcomes will be assessed at 6 and 12 months post-treatment. The approach aims to leverage the immune response triggered by localized heat to eliminate the fungal infection. The study includes a single-arm design, focusing on patient compliance and follow-up.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 70 with confirmed onychomycosis affecting at least two nails.
Not a fit: Patients who are pregnant, breastfeeding, or have certain systemic diseases may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive and effective option for patients suffering from onychomycosis.
How similar studies have performed: Previous studies have shown promising results for similar hyperthermia approaches in treating fungal infections, suggesting potential efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female patients between 18 and 70 years old. 2. Patients with Onychomycosis confirmed by clinic and microscopic examination or culture of fungi. 3. All subjects voluntarily joined this study with informed consents. 4. The subjects have good compliance and can cooperate with investigators follow-up study. Exclusion Criteria: 1. The patients during the period of pregnancy or breastfeeding. 2. The systemic and topical antifungal drugs were withdrawn 1 year and 3 months before enrollment, respectively. 3. Patients who suffered from progressive disease, autoimmune, tumor diseases or other diseases adjudged by the investigator to be inappropriate for inclusion into the study. 4. Other conditions adjudged by the investigator to be inappropriate for inclusion into the study.
Where this trial is running
Shenyang, Liaoning
- The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Xinghua Gao, PhD
- Email: gaobarry@hotmail.com
- Phone: +86 13940152467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.