Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus
Overview
- Phase
- Not Applicable
- Intervention
- CO2 fractional laser
- Conditions
- Vulva Lichen Sclerosus
- Sponsor
- Xijing Hospital
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Global Subjective Score 75（GSS75） rate
- Last Updated
- 4 years ago
Overview
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.
Investigators
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;
Arms & Interventions
Photodynamic treatment monotherapy or combined with CO2 fractional laser
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.
Intervention: CO2 fractional laser
Photodynamic treatment monotherapy or combined with CO2 fractional laser
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.
Intervention: 5-aminolevulinic acid (5-ALA) with red light illumination
Mometasone furoate cream
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: Mometasone furoate (MMF) 0.1% ointment
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Lichen Sclerosus Area （LSA）(2 weeks, 12 weeks, 6 months, 12months after the final treatment)
- Recurrence rate(6 months, 12 months after the final treatment)
- Global Subjective Score 75（GSS75）(12 weeks after the final treatment)
- Dermoscope Area Score （DAS）(2 weeks, 12 weeks, 6 months, 12 months after the final treatment)
- incidence of adverse events(up to 12 months)
- Global Objective Score（GOS）(2 weeks, 12 weeks, 6 months, 12 months after the final treatment)
- Quality of Life（QOL）(2 weeks, 12 weeks, 6 months, 12 months after the final treatment)