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

Vulvar Lichen Sclerosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250466
• Other study ID #: vulvar leukoplakia 2022
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Zhongnan Hospital
• Contact: Yuanzhen Zhang, professor
• Phone: +86 13545364853
• Email: wdzn2019[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study was designed as a prospective, multicenter, randomized, open-label, parallel-controlled clinical trial. The study population was patients with vulvar leukoplakia, and compared the efficacy and safety of AI temperature-controlled radio frequency technology and electrical stimulation in the treatment of vulvar leukoplakia. According to the research purpose, the sample size was calculated and determined to be 120 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 60 cases in the radio frequency observation group and 60 cases in the electric stimulation control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukoplakia
• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

Procedure:
• Radiofrequency technology
The vulva and vagina were routinely disinfected with iodophor, the negative plate was placed on the patient's waist and abdomen, and the vulva module was selected for treatment for 10 minutes per side, for a total of 20 minutes. Parameters: power 10-20W, temperature 38-42C°, once every 10 days, 5 times in total
• Electrical stimulation
Routine vulvovaginal disinfection with iodophor, vaginal probes are placed in channel A, electrode pads are placed in channels B\C\D respectively, the frequency of electrical stimulation (the most comfortable amount) is adjusted, 10 times is a course of treatment, and mild lesions are treated for 1-2 courses of treatment , 2 to 3 courses of treatment for moderate to severe lesions.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy index	Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%	6 month after treatment
Secondary	Recurrence rate	Percentage of recurrence of genital itching 6 months after treatment	6 month after treatment