๐ฌIn plain words
What the trial is, and whether it could suit you
Fractional ablative laser treatment for Lichen Sclerosus lesion
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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