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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
CO2 fraction laser
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).
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.
Dermatology Derpartment of Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGGlobal 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.
Time frame: 2 weeks after the final treatment
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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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.
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Time frame: 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).
Time frame: 2 weeks, 12 weeks, 6 months, 12 months after the final treatment
incidence of adverse events
incidence of adverse events
Time frame: up to 12 months