Vulva Lichen Sclerosus
Conditions
Keywords
vulva lichen sclerosus, female, CO2 Fractional Laser, Photodynamic Therapy
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.
Interventions
DEVICECO2 fractional laser
CO2 fraction laser
COMBINATION_PRODUCT5-aminolevulinic acid (5-ALA) with red light illumination
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).
DRUGMometasone furoate (MMF) 0.1% ointment
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.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-60 (inclusive), female patients; 2. present typical clinical manifestations of of vulvar lichen sclerosus, confirmed by histopathological examination; 3. Volunteer to participate in this study and sign an informed consent form.
Exclusion criteria
1. Severe organic diseases, such as severe heart, lung, liver, kidney insufficiency, coagulation dysfunction, etc.; 2. Suffer from autoimmune diseases, such as systemic lupus erythematosus, thyroid disease, etc.; 3. Suffer from photoallergic diseases, such as chronic photosensitivity dermatitis, plant solar dermatitis; 4. People with porphyria or porphyria allergy; 5. Suffer from psychiatric diseases, such as schizophrenia, etc.; 6. Those who are undergoing systemic treatment due to malignant tumor diseases, such as cervical cancer; 7. It is confirmed by laboratory pathogenic screening to have syphilis, HIV, and other sexually transmitted diseases or viral hepatitis; 8. Patients with current bacterial or fungal infections in the anus and genitals; 9. Women of childbearing age who have pregnancy plans, are pregnant, or are breastfeeding during the observation period of this study; 10. Patients who are systematically using glucocorticoids, immunosuppressants, and anticoagulants; 11. Use glucocorticoids for topical or local injection and calcineurin inhibitors for topical use within 4 weeks; 12. Those who are allergic to 5-aminolevulinic acid or its base, mometasone furoate or its base; 13. Other situations that the investigator considers inappropriate to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Subjective Score 75（GSS75） rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Global Subjective Score 75（GSS75） | 12 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) |
| Global Objective Score（GOS） | 2 weeks, 12 weeks, 6 months, 12 months after the final treatment | 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） | 2 weeks, 12 weeks, 6 months, 12months after the final treatment | The improvement of lichen sclerosus area from baseline by photograph documents with a standard scale |
| Recurrence rate | 6 months, 12 months after the final treatment | 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. |
| Dermoscope Area Score （DAS） | 2 weeks, 12 weeks, 6 months, 12 months after the final treatment | 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 | up to 12 months | incidence of adverse events |
| Quality of Life（QOL） | 2 weeks, 12 weeks, 6 months, 12 months after the final treatment | 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. |
Countries
China
Contacts
Primary ContactGuannan Zhu
Outcome results
None listed