Laser treatment for lichen sclerosus lesions

Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion

This study is testing if a special laser treatment can help women with vulvar lichen sclerosus feel better by reducing symptoms like dryness, itching, and pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Sciton (industry)
• Locations: 1 site (Val-d'Or, Quebec)
• Trial ID: NCT06389071 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of fractional ablative laser treatment specifically for women suffering from vulvar lichen sclerosus lesions. Participants will undergo treatment using a 2940 nm laser, aimed at alleviating symptoms such as dryness, itching, and pain. The study will include women aged 18 and older with biopsy-proven lichen sclerosus and will monitor their response to the treatment over a series of scheduled follow-up visits. The trial emphasizes the importance of informed consent and the collection of clinical photographs and ultrasound images for assessment.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older with biopsy-confirmed vulvar lichen sclerosus who experience related symptoms.

Not a fit: Patients who are pregnant, nursing, or planning to become pregnant during the study will not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for women suffering from lichen sclerosus by alleviating painful symptoms.

How similar studies have performed: While there is limited data on the use of laser treatment for lichen sclerosus, similar approaches in dermatological conditions have shown promising results.

Eligibility criteria

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

Where this trial is running

Val-d'Or, Quebec

• Clinique Medicale Uro-Gyneco de l'Abitibi — Val-d'Or, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Josee Parent, MD — Clinique Medicale Uro-Gyneco de l'Abitibi
• Study coordinator: J Patel

Conditions: Lichen Sclerosus Lesion