A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFebruary 5, 2024
October 1, 2023
1.7 years
February 10, 2022
February 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy index
Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%
6 month after treatment
Secondary Outcomes (1)
Recurrence rate
6 month after treatment
Study Arms (2)
Radiofrequency group
EXPERIMENTALAI Temperature-controlled Radiofrequency Technology
Electrical stimulation group
ACTIVE COMPARATORElectrical Stimulation
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
- to 60 years old;
- Agree to sign the informed consent;
You may not qualify if:
- Patients with severe liver and kidney dysfunction;
- Combined with HIV, syphilis infection, acute vaginitis, cervical cancer;
- Patients with cardiovascular disease;
- People with hematological diseases;
- Patients with hypertension and diabetes;
- People with mental illness;
- Pregnant and lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yuanzhen Zhang, Professor
Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2022
First Posted
February 22, 2022
Study Start
July 7, 2022
Primary Completion
March 1, 2024
Study Completion
June 30, 2024
Last Updated
February 5, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share