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Search / Trial NCT06036654

Infrared Bioeffect System for the Treatment of Onychomycosis

Launched by GAO XINGHUA · Sep 12, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hyperthermia Onychomycosis

ClinConnect Summary

This clinical trial is studying a new treatment for onychomycosis, which is a fungal infection of the nails that can be hard to treat effectively. Researchers are testing a special device called the controllable infrared bioeffect system, which uses heat in a safer and less painful way compared to traditional laser treatments. The goal is to see if this new method is safe and effective for helping people with onychomycosis, especially since current treatments can be expensive and often don’t work for everyone.

To participate in the trial, you need to be between 18 and 70 years old and have a confirmed diagnosis of onychomycosis. You must also be willing to follow the study guidelines and attend follow-up appointments. However, if you are pregnant, breastfeeding, or have certain health conditions like autoimmune diseases, you may not be eligible. If you join the study, you can expect to receive treatment from this new device and help researchers understand its benefits for others dealing with this common nail infection.

Gender

ALL

Eligibility 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 The systemic and topical antifungal drugs were withdrawn 1 year and 3 months before enrollment, respectively.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.

About Gao Xinghua

Gao Xinghua is a dedicated clinical trial sponsor known for advancing medical research and innovation. With a focus on developing novel therapeutic solutions, the organization is committed to ensuring the highest standards of safety and efficacy in clinical studies. Leveraging a robust network of collaborations with healthcare professionals and research institutions, Gao Xinghua aims to address unmet medical needs through rigorous trial design and execution. Their expertise spans various therapeutic areas, reflecting a commitment to improving patient outcomes and contributing to the global healthcare landscape.

Locations

Shenyang, Liaoning, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported