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

Zhongnan Hospital

Status: Enrolling

Conditions: Vulvar Lichen Sclerosus

Treatments: Procedure: Electrical stimulation; Procedure: Radiofrequency technology

Study type: Interventional

Funder types: Other

Identifiers

NCT05250466

vulvar leukoplakia 2022

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Radiofrequency group

Experimental group

Description:

AI Temperature-controlled Radiofrequency Technology

Treatment:

Procedure: Radiofrequency technology

Electrical stimulation group

Active Comparator group

Description:

Electrical Stimulation

Treatment:

Procedure: Electrical stimulation