Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus

Официальное название

Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus

Обзор

With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.

Подробное описание

Vulvar Lichen sclerosus (VLS) is a chronic inflammatory cutaneous disorder, which can lead to scarring, impaired sexual function and malignancy. Gold standard treatment is topical corticosteroids (TCS) initially daily for 12 weeks. To avoid new flourishing of the disease a life-long maintenance treatment 2x/week is later recommended. Fractional CO2-Laser has shown a positive effect on vulvovaginal skin quality with improvement of urogenital atrophy and also lichen sclerosus. This randomised trial compares efficacy of laser treatment to TCS maintenance as well as the duration of the laser effect.

Вмешательства

• Устройство Treatment with Monalisa Glide Laser
  3 fractional laser treatment-sessions with Monalisa Glide
• Препарат Treatment with Clobetasol
  Application of Clobetasol twice per week

Первичные конечные точки

• Lichen Score [Срок оценки: 3 months]

Вторичные конечные точки (3)

• Lichen Score Follow up [Срок оценки: 15 months]
• Vulva assessment Scale [Срок оценки: 15 months]
• German Pelvic floor questionnaire [Срок оценки: 15 months]

Критерии участия

Критерии включения

• Pre- or postmenopausal
• 12 weeks of continuous topical clobetasol treatment completed.
• Written informed consent
• German speaking (Study information and IC available only in German)

Критерии исключения

• Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use
• Contraindication for the use of topic clobetasol
• History of vulva laser
• Immune-suppression
• Pregnancy or planned pregnancy, breast feeding.
• Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer.
• History of vulvar or pelvic radiation therapy
• Uncertain vulvar findings, which require a biopsy.
• Acute vulvitis, especially recurrent genital herpes
• History of vaginal mesh implantation within 6 months preceding this study
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
• Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
• Previous enrolment into the current investigation
• Enrolment of the PI, his/her family members, employees and other dependent persons

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Kantonsspital Winterthur — Winterthur

Идентификаторы

NCT: NCT06135402 · Laser-Lichen

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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