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

Sponsor

Zhongnan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05250466

Collaborator

(none)

260

Enrollment

Location

Arms

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Lichen Sclerosus	Procedure: Radiofrequency technology Procedure: Electrical stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1	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
Active Comparator: Group 2	Procedure: 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.

Arm

Intervention/Treatment

Experimental: Group 1

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

Active Comparator: Group 2

Procedure: 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.

Outcome Measures

Primary Outcome Measures

clinical efficacy [1 month after treatment]
Effective rate: number of improved cases/total number of cases × 100%
clinical efficacy [3 month after treatment]
Effective rate: number of improved cases/total number of cases × 100%
clinical efficacy [6 month after treatment]
Effective rate: number of improved cases/total number of cases × 100%

Secondary Outcome Measures

Recurrence rate [6 month after treatment]
Percentage of recurrence of genital itching 6 months after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China

Sponsors and Collaborators

Zhongnan Hospital

Investigators

Study Chair: Yuanzhen Zhang, Professor, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhongnan Hospital

ClinicalTrials.gov Identifier:

NCT05250466

Other Study ID Numbers:

vulvar leukoplakia 2022

First Posted:

Feb 22, 2022

Last Update Posted:

Feb 22, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukoplakia

Vulvar Lichen Sclerosus

Lichen Sclerosus et Atrophicus

Study Results

No Results Posted as of Feb 22, 2022