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Набира участници Не е приложимо NCT06389071

Laser Treatment for Lichen Sclerosus

Не е приложима фаза (напр. обсервационно)
Заболявания: Lichen Sclerosus Lesion

Спонсор: Sciton

Налично на: БГ
Обобщение
Fractional ablative laser treatment for Lichen Sclerosus lesion
Кой може да участва
Inclusion Criteria: * Female aged 18 years or older * Biopsy-proven vulvar lichen sclerosus lesion * Experiencing one or more of the following symptoms of LS: 1. Dryness 2. Itching 3. Burning 4. Bleeding 5. Blistering 6. Soreness 7. Easily bruises 8. Easily tears 9. Ulcerated lesions 10. Painful intercourse * Negative urine pregnancy test if subject is of childbearing potential before enrollment * Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI * Ability to understand and sign informed consent, questionnaires, and all investigation requirements * Willing to consent to clinical photographs of the treatment area * Willing to consent to ultrasound images of the treatment area * Willing and able to logistically follow schedule of treatments and follow-up visits Exclusion Criteria: * Pregnancy, less than 3 months postpartum, or planning to become pregnant during the investigation to protect integrity of the data * Is a nursing mother * History of uncontrolled malignant disease * Active urogenital infection or chronic infection (i.e., candida, herpes, herpes simplex, bacterial vaginosis, trichomoniasis, or other infection) * Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich syndrome) * Subjects with genital skin disease, psoriasis due to risk of koeberizing * Subjects on immunosuppressants: mycophenolate, retinoids, azathioprine, cyclosporin * Known allergy or intolerance to local anesthesia * Known history of connective tissue disease * Known propensity for keloid formations * Known medical condition that may affect wound healing * Any reason that the investigator deems prohibits participation in the investigation
Интервенции
Fractional 2940 nm Laser
DEVICE
Места на провеждане 1
Канада (1)
Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or , Quebec
Josee Parent, MD
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Само жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.03.2024
Крайна дата
30.12.2027
Регистрационен номер
NCT06389071
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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