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5-Aminolevulinic acid photodynamic therapy in refractory vulvar lichen sclerosus et atrophicus: Series of ten cases.

ABSTRACT: BACKGROUND:Vulvar lichen sclerosus et atrophicus (VLSA) is a chronic inflammatory skin disease of unknown etiology that mainly affects postmenopausal and perimenopausal women. The primary clinical symptoms of VLSA are itching, burning pain, and dyspareunia that can results in decreased quality of life. Existing therapies including topical corticosteroid ointment, topical calcineurin inhibitors, estrogens, are not very effective for treatment of VLSA. OBJECTIVE:To evaluate the effectiveness and safety of 5-aminolevulinic acid mediated photodynamic therapy (ALA-PDT) in the treatment of VLSA. MATERIALS AND METHODS:Ten patients with VLSA who had failed conventional treatment received ALA-PDT. 10% 5-ALA in an oil-in-water emulsion was applied to the lesions and occluded with plastic film for 3?h, when the lesions were irradiated with 100?mW/cm2, 635 ± 15?nm red light for 20?min. Treatments were repeated three times at 2-week intervals. Objective and subjective symptoms and signs of the vulvar lesions based on horizontal visual analogue scales were recorded at each treatment and 1, 3, and 6 months after the last session. The quality of life was assessed using dermatology life quality index (DLQI) questionnaire. RESULTS:All patients completed three ALA-PDT treatments and the follow-up visits. Clinical symptoms of itching disappeared completely in nine patients, one patient had itching decreased from severe to mild. All subjects showed objective improvement in lesions. The DLQI of all cases improved after treatment. The main side-effects of ALA-PDT were pain, erythema, and swelling. Side-effects were transient and tolerable. All patients reported being "satisfied" or "very satisfied" with their outcomes. CONCLUSIONS:ALA-PDT is an effective and safe approach for the treatment of VLSA.

SUBMITTER: Lan T

PROVIDER: S-EPMC5922423 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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5-Aminolevulinic acid photodynamic therapy in refractory vulvar lichen sclerosus et atrophicus: Series of ten cases.

Lan Ting T Zou Yongzhen Y Hamblin Michael R MR Yin Rui R

Photodiagnosis and photodynamic therapy 20171216

<h4>Background</h4>Vulvar lichen sclerosus et atrophicus (VLSA) is a chronic inflammatory skin disease of unknown etiology that mainly affects postmenopausal and perimenopausal women. The primary clinical symptoms of VLSA are itching, burning pain, and dyspareunia that can results in decreased quality of life. Existing therapies including topical corticosteroid ointment, topical calcineurin inhibitors, estrogens, are not very effective for treatment of VLSA.<h4>Objective</h4>To evaluate the effe ...[more]

PMID: 29258952

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Project description:ObjectiveTo estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus.MethodsWe conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus).ResultsFrom November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI -1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI -0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI -1.14, 1.06, P=.76).ConclusionFractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus.Clinical trial registrationClinicalTrials.gov, NCT03665584.Funding sourceAdditional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.

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5-Aminolevulinic acid photodynamic therapy in refractory vulvar lichen sclerosus et atrophicus: Series of ten cases.

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5-Aminolevulinic acid photodynamic therapy in refractory vulvar lichen sclerosus et atrophicus: Series of ten cases.

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