Vulvar Lichen SclerosusNCT05250466
A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
A study testing Radiofrequency technology and Electrical stimulation in people with Vulvar Lichen Sclerosus, run by Zhongnan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Vulvar Lichen Sclerosus
- What is being tested?
- Radiofrequency technology and Electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
- 18 to 60 years old;
- Agree to sign the informed consent;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Yuanzhen Zhang
Yuanzhen Zhang
About this study
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.
- Conditions
- Vulvar Lichen Sclerosus
- Being tested
- Radiofrequency technology, Electrical stimulation
- Medical subject headings
- Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency technologyProcedure or surgery
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
Electrical stimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency group | Experimental | AI Temperature-controlled Radiofrequency Technology Receives: Procedure: Radiofrequency technology |
| Electrical stimulation group | Active comparator | Electrical Stimulation Receives: Procedure: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy index
Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%
Measured: 6 month after treatment
Secondary outcomes (1)
Recurrence rate
Percentage of recurrence of genital itching 6 months after treatment
Measured: 6 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start7 Jul 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar Lichen SclerosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuanzhen Zhang, Professor, Study chair, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250466
- Sponsor's protocol ID
- vulvar leukoplakia 2022
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Efficacy of AI Temperature-controlled Radiofrequency Technology and Electrical Stimulation in the Treatment of Vulvar Leukoplakia
- ClinicalTrials.gov ID
- NCT05250466
- Acronym / sponsor ID
- vulvar leukoplakia 2022
- Conditions
- Vulvar Lichen Sclerosus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency group | Experimental | Procedure: Radiofrequency technologyAI Temperature-controlled Radiofrequency Technology |
| Electrical stimulation group | Active comparator | Procedure: Electrical stimulationElectrical Stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed by pathological examination, meeting the diagnostic criteria for leukoplakia;
- 18 to 60 years old;
- Agree to sign the informed consent;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency technologyThe 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 | Procedure or surgery | Radiofrequency group |
| Electrical stimulationRoutine 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. | Procedure or surgery | Electrical stimulation group |
Primary outcome
Efficacy index
Time frame: 6 month after treatment
Efficacy index: (score before treatment-score after treatment)/(score before treatment)×100%
1 secondary outcome
Recurrence rate
Time frame: 6 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Vulvar Lichen Sclerosus
Not yet recruitingPhase 2
Nemolizumab for LS
Lichen Sclerosus of Vulva
Not yet recruiting
Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
Vulvar Lichen Sclerosus, Vulvar Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Recruiting
Dynamic Quadripolar Radiofrequency VS Topical Corticosteroids in Women With Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
RecruitingPhase 2
Methotrexate for Severe Vulvar Lichen Sclerosus
Vulvar Lichen Sclerosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanzhen Zhang, Professor study chair
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency technology and Electrical stimulation in people with Vulvar Lichen Sclerosus, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanzhen Zhang, professor (+86 13545364853, wdzn2019@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy index (time frame: 6 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.