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Recruiting Not applicable NCT06389071

Laser Treatment for Lichen Sclerosus

No applicable phase (e.g. observational)
Conditions: Lichen Sclerosus Lesion

Sponsor: Sciton

trial.available_in: БГ
Overview
Fractional ablative laser treatment for Lichen Sclerosus lesion
Who can participate
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
Interventions
Fractional 2940 nm Laser
DEVICE
Locations 1
Canada (1)
Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or , Quebec
Josee Parent, MD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
01.03.2024
Completion date
30.12.2027
Registry ID
NCT06389071
Source
clinicaltrials.gov
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