Back to resultsCarbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus
Primary Purpose
Vulva Lichen Sclerosus
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CO2 fractional laser
5-aminolevulinic acid (5-ALA) with red light illumination
Mometasone furoate (MMF) 0.1% ointment
Sponsored by
About this trial
This is an interventional treatment trial for Vulva Lichen Sclerosus focused on measuring vulva lichen sclerosus, female, CO2 Fractional Laser, Photodynamic Therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Dermatology Derpartment of Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Photodynamic treatment monotherapy or combined with CO2 fractional laser
Mometasone furoate cream
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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)
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.
Lichen Sclerosus Area （LSA）
The improvement of lichen sclerosus area from baseline by photograph documents with a standard scale
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.
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).
incidence of adverse events
incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05228483
Brief Title
Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus
Official Title
Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulva Lichen Sclerosus
Keywords
vulva lichen sclerosus, female, CO2 Fractional Laser, Photodynamic Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photodynamic treatment monotherapy or combined with CO2 fractional laser
Arm Type
Experimental
Arm Description
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.
Arm Title
Mometasone furoate cream
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CO2 fractional laser
Intervention Description
CO2 fraction laser
Intervention Type
Combination Product
Intervention Name(s)
5-aminolevulinic acid (5-ALA) with red light illumination
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate (MMF) 0.1% ointment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global Subjective Score 75（GSS75） rate
Description
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.
Time Frame
2 weeks after the final treatment
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
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.
Time Frame
6 months, 12 months after the final treatment
Title
Global Subjective Score 75（GSS75）
Description
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)
Time Frame
12 weeks after the final treatment
Title
Global Objective Score（GOS）
Description
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.
Time Frame
2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Title
Lichen Sclerosus Area （LSA）
Description
The improvement of lichen sclerosus area from baseline by photograph documents with a standard scale
Time Frame
2 weeks, 12 weeks, 6 months, 12months after the final treatment
Title
Quality of Life（QOL）
Description
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.
Time Frame
2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Title
Dermoscope Area Score （DAS）
Description
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).
Time Frame
2 weeks, 12 weeks, 6 months, 12 months after the final treatment
Title
incidence of adverse events
Description
incidence of adverse events
Time Frame
up to 12 months
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:
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guannan Zhu
Phone
+8615191881772
Email
to_rain77@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guannan Zhu
Organizational Affiliation
Dermatology Derpartment of Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Derpartment of Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Wang
Phone
+8684775401
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Carbon Dioxide（CO2）Fractional Laser Plus Photodynamic Therapy in Female Patients With Vulvar Lichen Sclerosus
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