Laser Treatment for Lichen Sclerosus

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 beforeenrollment

• Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI

• Ability to understand and sign informed consent, questionnaires, and allinvestigation 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 theinvestigation 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, herpessimplex, 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