Back to resultsA Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
Primary Purpose
Vulvar Lichen Sclerosus
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radiofrequency technology
Electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Vulvar Lichen Sclerosus
Eligibility Criteria
Inclusion Criteria:
- Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
- 18 to 60 years old;
- Agree to sign the informed consent;
Exclusion Criteria:
- 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.
Sites / Locations
- Zhongnan Hospital of Wuhan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radiofrequency group
Electrical stimulation group
Arm Description
AI Temperature-controlled Radiofrequency Technology
Electrical Stimulation
Outcomes
Primary Outcome Measures
Efficacy index
Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%
Secondary Outcome Measures
Recurrence rate
Percentage of recurrence of genital itching 6 months after treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05250466
Brief Title
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
Official Title
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongnan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 260 cases, and they were randomly assigned to the observation group and the control group according to the ratio of 1:1, namely 130 cases in the radio frequency observation group and 130 cases in the electric stimulation control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Lichen Sclerosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency group
Arm Type
Experimental
Arm Description
AI Temperature-controlled Radiofrequency Technology
Arm Title
Electrical stimulation group
Arm Type
Active Comparator
Arm Description
Electrical Stimulation
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency technology
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy index
Description
Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%
Time Frame
6 month after treatment
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Percentage of recurrence of genital itching 6 months after treatment
Time Frame
6 month after treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
18 to 60 years old;
Agree to sign the informed consent;
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanzhen Zhang, professor
Phone
+86 13545364853
Email
wdzn2019@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kejia Wu, Doctor
Phone
+86 13545364853
Email
wdzn2019@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanzhen Zhang, Professor
Organizational Affiliation
Wuhan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanzhen Zhang
First Name & Middle Initial & Last Name & Degree
Yuanzhen Zhang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
We'll reach out to this number within 24 hrs