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

Not Applicable

Recruiting

• Conditions: Vulvar Lichen Sclerosus
• Interventions: Procedure: Radiofrequency technology; Procedure: Electrical stimulation

• Registration Number: NCT05250466
• Lead Sponsor: Zhongnan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-22
• Study Start: 2022-07-07
• Status Verified: 2023-10
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency group	Radiofrequency technology	AI Temperature-controlled Radiofrequency Technology
Electrical stimulation group	Electrical stimulation	Electrical Stimulation

Primary Outcome Measures

Name	Time	Method
Efficacy index	6 month after treatment	Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	6 month after treatment	Percentage of recurrence of genital itching 6 months after treatment

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China