Overview

Fractional ablative laser treatment for Lichen Sclerosus lesion

Eligibility

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