Laser Treatment for Lichen Sclerosus

Sciton

Status: Enrolling

Conditions: Lichen Sclerosus Lesion

Treatments: Device: Fractional 2940 nm Laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT06389071

PLS001

Details and patient eligibility

About

Fractional ablative laser treatment for Lichen Sclerosus lesion

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Treatment + PRP Arm

Active Comparator group

Treatment:

Device: Fractional 2940 nm Laser

Treatment only Arm

Active Comparator group

Treatment:

Device: Fractional 2940 nm Laser