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A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia

Launched by ZHONGNAN HOSPITAL · Feb 10, 2022

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking into two different treatments for a condition called vulvar leukoplakia, which affects the skin in the genital area of women. The study aims to compare the effectiveness and safety of two methods: one uses advanced technology that controls heat (AI temperature-controlled radiofrequency), and the other uses electrical stimulation. A total of 120 women, ages 18 to 60, who have been diagnosed with this condition will participate. They will be randomly divided into two groups, with one receiving the radiofrequency treatment and the other receiving electrical stimulation.

To join this trial, participants must be women diagnosed with vulvar leukoplakia through a medical examination and be between the ages of 18 to 60. However, certain individuals are excluded, such as those with serious health issues like liver or kidney problems, certain infections, or conditions like heart disease, diabetes, or hypertension. Participants can expect to receive one of the two treatments and will be monitored for their safety and how well the treatment works. The study is currently recruiting participants, and it's a great opportunity for those looking for new treatment options.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
  • 2. 18 to 60 years old;
  • 3. Agree to sign the informed consent;
  • Exclusion Criteria:
  • 1. Patients with severe liver and kidney dysfunction;
  • 2. Combined with HIV, syphilis infection, acute vaginitis, cervical cancer;
  • 3. Patients with cardiovascular disease;
  • 4. People with hematological diseases;
  • 5. Patients with hypertension and diabetes;
  • 6. People with mental illness;
  • 7. Pregnant and lactating women.

About Zhongnan Hospital

Zhongnan Hospital, affiliated with Wuhan University, is a leading medical institution in China renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on multidisciplinary collaboration, the hospital employs state-of-the-art facilities and a team of highly skilled professionals to conduct rigorous clinical studies aimed at improving patient outcomes. Zhongnan Hospital prioritizes ethical standards and patient safety, ensuring adherence to regulatory requirements while fostering a culture of scientific excellence. As a prominent sponsor of clinical trials, the hospital plays a pivotal role in contributing to the global medical community and enhancing the understanding of various health conditions.

Locations

Wuhan, Hubei, China

Patients applied

0 patients applied

Trial Officials

Yuanzhen Zhang, Professor

Study Chair

Wuhan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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