Laser Treatment for Lichen Sclerosus

Not Applicable

Recruiting

• Conditions: Lichen Sclerosus Lesion

• Registration Number: NCT06389071
• Lead Sponsor: Sciton

Brief Summary

Fractional ablative laser treatment for Lichen Sclerosus lesion

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-20
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Histological clearance	16 weeks	Efficacy of the treatment is determined by histological changes measured at 16 weeks post final treatment

Trial Locations

Locations (1)

Clinique Medicale Uro-Gyneco de l'Abitibi; 🇨🇦 Val-d'Or, Quebec, Canada