Lichen Sclerosus Lesion
Conditions
Brief summary
Fractional ablative laser treatment for Lichen Sclerosus lesion
Interventions
DEVICEFractional 2940 nm Laser
Fractional 2940 nm Laser
Sponsors
Sciton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological clearance | 16 weeks | Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment |
Countries
Canada
Contacts
CONTACTJ Patel
PRINCIPAL_INVESTIGATORJosee Parent, MD
Clinique Medicale Uro-Gyneco de l'Abitibi
Outcome results
None listed