Vulva Lichen SclerosusNCT05228483
Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus
A study testing CO2 fractional laser, 5-aminolevulinic acid (5-ALA) with red light illumination and Mometasone furoate (MMF) 0.1% ointment in people with Vulva Lichen Sclerosus, run by Xijing Hospital at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Vulva Lichen Sclerosus
- What is being tested?
- CO2 fractional laser, 5-aminolevulinic acid (5-ALA) with red light illumination and Mometasone furoate (MMF) 0.1% ointment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2021to 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
- Age 18-60 (inclusive), female patients;
- present typical clinical manifestations of of vulvar lichen sclerosus, confirmed by histopathological examination;
- Volunteer to participate in this study and sign an informed consent form.
Who cannot join
- Severe organic diseases, such as severe heart, lung, liver, kidney insufficiency, coagulation dysfunction, etc.;
- Suffer from autoimmune diseases, such as systemic lupus erythematosus, thyroid disease, etc.;
- Suffer from photoallergic diseases, such as chronic photosensitivity dermatitis, plant solar dermatitis;
- People with porphyria or porphyria allergy;
- Suffer from psychiatric diseases, such as schizophrenia, etc.;
- Those who are undergoing systemic treatment due to malignant tumor diseases, such as cervical cancer;
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- It is confirmed by laboratory pathogenic screening to have syphilis, HIV, and other sexually transmitted diseases or viral hepatitis;
- Patients with current bacterial or fungal infections in the anus and genitals;
- Women of childbearing age who have pregnancy plans, are pregnant, or are breastfeeding during the observation period of this study;
- Patients who are systematically using glucocorticoids, immunosuppressants, and anticoagulants;
- Use glucocorticoids for topical or local injection and calcineurin inhibitors for topical use within 4 weeks;
- Those who are allergic to 5-aminolevulinic acid or its base, mometasone furoate or its base;
- Other situations that the investigator considers inappropriate to participate in the clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Wang, +8684775401
About this study
Official title: Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus
The objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.
Read the detailed description
This is a randomized, open-labeled, assessor-blind, parallel control study. 134 enrolled patients will be randomized to apply either topical 0.1% corticosteroid mometasone furoate(MMF) ointment or photodynamic therapy.
For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive CO2 fractional laser before photodynamic therapy, while the other side will receive photodynamic therapy only.
- Conditions
- Vulva Lichen Sclerosus
- Being tested
- CO2 fractional laser, 5-aminolevulinic acid (5-ALA) with red light illumination, Mometasone furoate (MMF) 0.1% ointment
- Keywords
- vulva lichen sclerosus, female, CO2 Fractional Laser, Photodynamic Therapy
- 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.
CO2 fractional laserDevice
CO2 fraction laser
5-aminolevulinic acid (5-ALA) with red light illuminationCombination product
5-aminolevulinic acid (5-ALA) is a photosensitizing agent which can induce photochemical reactions in tissues in response to an appropriate wavelength of light (red light 630-635nm).
Mometasone furoate (MMF) 0.1% ointmentDrug
0.1% Mometasone furoate ointment is a potent steroid and has been proven to result as efficacious and well tolerated as clobetasol propionate which represent the recomended first-line treatment of vulvar lichen sclerosus.
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic treatment monotherapy or combined with CO2 fractional laser | Experimental | For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive 5-aminolevulinic acid (5-ALA) with a red light illumination(80mW/cm2, and 120J/ cm2); while the other side will receive CO2 fractional laser(parameter: 20mm *20mm, spot coverage rate 10%, and 18-25mJ/cm2) before photodynamic therapy. Treating area should cover 0.5cm beyond the visible boundary of the lesion. In total 6 therapies will be given for each patient, with 14±3d intervals. Receives: Device: CO2 fractional laser; Combination Product: 5-aminolevulinic acid (5-ALA) with red light illumination |
| Mometasone furoate cream | Active comparator | Mometasone furoate cream (0.1%) for topical application, frequency: once daily, 5 days/week, for the first month; once every other day, for the second month; twice a week for the third month; the area of application should cover 0.5cm beyond the visible boundary of the lesion. Receives: Drug: Mometasone furoate (MMF) 0.1% ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Subjective Score 75（GSS75） rate
GSS75 is defined as ≥75% improvement from baseline in global subjective score using pain and itching visual analog scales with score from 0 (absent) to 10 (most severe imaginable). GSS75 rate is the rate of patients achieving GSS75.
Measured: 2 weeks after the final treatment
Secondary outcomes (7)
Recurrence rate
Recurrence rate: the number of patients relapse/the number of patients who completed all treatment. Relapse is defined as an increase of 1 point in any of the six indicators of GOS, or an increase of ≥ 3 points in any of the GSS, or an increase of 1 point in any of the QOL compared with that at the 2-week visit after the final treatment.
Measured: 6 months, 12 months after the final treatment
Global Subjective Score 75（GSS75）
GSS75 is defined as ≥75% improvement from baseline in global subjective score using pain and itching visual analog scales with score from 0 (absent) to 10 (most severe imaginable)
Measured: 12 weeks after the final treatment
Global Objective Score（GOS）
Sum of scores in 6 aspects: Erythema, leukoplakia, hyperkeratosis, purpuric lesions, degree of sclerosis, scar-like atrophy (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Range : 0 - 18.
Measured: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Lichen Sclerosus Area （LSA）
The improvement of lichen sclerosus area from baseline by photograph documents with a standard scale
Measured: 2 weeks, 12 weeks, 6 months, 12months after the final treatment
Quality of Life（QOL）
Sum of scores of four indexes: dysuria, defecation difficulty, dysesthesia and dyspareunia (applicable patients) ( 0 = absent, 1 = mild, 2 = moderate, 3 = severe). Range: 0-12.
Measured: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Dermoscope Area Score （DAS）
Dermoscope assessment of vessel morphology, bright white or white- yellowish structureless areas, shiny white streaks, purple dots, peppering blue-gray dots, erosions, and rose petal sign ( 0 = absent, 1 = mild, 2 = moderate, 3 = severe).
Measured: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
incidence of adverse events
incidence of adverse events
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start23 Nov 2021
- Primary completion30 Nov 2023 (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 Vulva Lichen SclerosusStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guannan Zhu, Principal investigator, Dermatology Derpartment of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228483
- Sponsor's protocol ID
- XijingH-PF-20211102
- Status last verified
- Nov 2021
- First submitted
- 22 Dec 2021
- Last updated
- 8 Feb 2022
- 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 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT05228483
- Acronym / sponsor ID
- XijingH-PF-20211102
- Conditions
- Vulva Lichen Sclerosus
- Keywords
- vulva lichen sclerosus, female, CO2 Fractional Laser, Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 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 objective of this study is to evaluate the safety and efficacy of CO2 fractional laser combined with photodynamic therapy in female patients with vulvar lichen sclerosus.
Detailed description
This is a randomized, open-labeled, assessor-blind, parallel control study. 134 enrolled patients will be randomized to apply either topical 0.1% corticosteroid mometasone furoate(MMF) ointment or photodynamic therapy.
For patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive CO2 fractional laser before photodynamic therapy, while the other side will receive photodynamic therapy only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photodynamic treatment monotherapy or combined with CO2 fractional laser | Experimental | Device: CO2 fractional laser, Combination Product: 5-aminolevulinic acid (5-ALA) with red light illuminationFor patients who receive photodynamic therapy, lesions will be symmetrically randomized into two sides. One side will receive 5-aminolevulinic acid (5-ALA) with a red light illumination(80mW/cm2, and 120J/ cm2); while the other side will receive CO2 fractional laser(parameter: 20mm *20mm, spot coverage rate 10%, and 18-25mJ/cm2) before photodynamic therapy. Treating area should cover 0.5cm beyond the visible boundary of the lesion. In total 6 therapies will be given for each patient, with 14±3d intervals. |
| Mometasone furoate cream | Active comparator | Drug: Mometasone furoate (MMF) 0.1% ointmentMometasone furoate cream (0.1%) for topical application, frequency: once daily, 5 days/week, for the first month; once every other day, for the second month; twice a week for the third month; the area of application should cover 0.5cm beyond the visible boundary of the lesion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 (inclusive), female patients;
- present typical clinical manifestations of of vulvar lichen sclerosus, confirmed by histopathological examination;
- Volunteer to participate in this study and sign an informed consent form.
Key exclusion criteria (13 listed)
- Severe organic diseases, such as severe heart, lung, liver, kidney insufficiency, coagulation dysfunction, etc.;
- Suffer from autoimmune diseases, such as systemic lupus erythematosus, thyroid disease, etc.;
- Suffer from photoallergic diseases, such as chronic photosensitivity dermatitis, plant solar dermatitis;
- People with porphyria or porphyria allergy;
- Suffer from psychiatric diseases, such as schizophrenia, etc.;
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 |
|---|---|---|
| CO2 fractional laserCO2 fraction laser | Device | Photodynamic treatment monotherapy or combined with CO2 fractional laser |
| 5-aminolevulinic acid (5-ALA) with red light illumination5-aminolevulinic acid (5-ALA) is a photosensitizing agent which can induce photochemical reactions in tissues in response to an appropriate wavelength of light (red light 630-635nm). | Combination product | Photodynamic treatment monotherapy or combined with CO2 fractional laser |
| Mometasone furoate (MMF) 0.1% ointment0.1% Mometasone furoate ointment is a potent steroid and has been proven to result as efficacious and well tolerated as clobetasol propionate which represent the recomended first-line treatment of vulvar lichen sclerosus. | Drug | Mometasone furoate cream |
Primary outcome
Global Subjective Score 75（GSS75） rate
Time frame: 2 weeks after the final treatment
GSS75 is defined as ≥75% improvement from baseline in global subjective score using pain and itching visual analog scales with score from 0 (absent) to 10 (most severe imaginable). GSS75 rate is the rate of patients achieving GSS75.
7 secondary outcomes
Recurrence rate
Time frame: 6 months, 12 months after the final treatment
Global Subjective Score 75（GSS75）
Time frame: 12 weeks after the final treatment
Global Objective Score（GOS）
Time frame: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Lichen Sclerosus Area （LSA）
Time frame: 2 weeks, 12 weeks, 6 months, 12months after the final treatment
Quality of Life（QOL）
Time frame: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Dermoscope Area Score （DAS）
Time frame: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
incidence of adverse events
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Guannan Zhu principal investigator
Dermatology Derpartment of Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 fractional laser, 5-aminolevulinic acid (5-ALA) with red light illumination and Mometasone furoate (MMF) 0.1% ointment in people with Vulva Lichen Sclerosus, run by Xijing 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 13 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 8 Feb 2022. 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 Guannan Zhu (+8615191881772, to_rain77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Subjective Score 75（GSS75） rate (time frame: 2 weeks after the final 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 8 Feb 2022.