Actively Recruiting
Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
Led by Sciton · Updated on 2026-04-23
50
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies fractional ablative laser treatment for women with Lichen Sclerosus lesions. It aims to evaluate the safety and effectiveness of a 2940 nm fractional laser device in treating these lesions. The study focuses on women aged 18 years or older who have biopsy-proven vulvar lichen sclerosus and symptoms such as dryness, itching, burning, bleeding, blistering, soreness, bruising, tearing, ulcerated lesions, or painful intercourse. Participants are randomly assigned to one of two groups: one receiving the fractional 2940 nm laser treatment combined with platelet-rich plasma (PRP), and the other receiving the laser treatment alone. The treatments are delivered using the fractional laser device, and the study compares these two approaches to assess their effects. The study does not mention specific dosing schedules but involves follow-up visits and assessments. Throughout the study, participants will undergo various evaluations including clinical photographs and ultrasound imaging of the treatment area. Researchers will measure histological clearance of the lesions at 16 weeks as the primary outcome. Participants must be able to follow the treatment and follow-up schedule and provide informed consent. Safety monitoring includes exclusion of participants with infections or conditions that may affect wound healing, and pregnancy testing before enrollment. The study duration extends to at least 16 weeks for primary outcome assessment.
CONDITIONS
Brief Title
Laser Treatment for Lichen Sclerosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Biopsy-proven vulvar lichen sclerosus lesion
- Experiencing one or more symptoms of lichen sclerosus such as dryness, itching, burning, bleeding, blistering, soreness, bruising, tearing, ulcerated lesions, or painful intercourse
- Negative urine pregnancy test if of childbearing potential before enrollment
- Absence of vulvovaginal infection including fungi, bacterial vaginosis, and sexually transmitted infections
- Ability to understand and sign informed consent, questionnaires, and all study-related requirements
- Willing to consent to clinical photographs and ultrasound images of the treatment area
- Willing and able to follow the schedule of treatments and follow-up visits
You will not qualify if you...
- Pregnant, less than 3 months postpartum, or planning to become pregnant during the study
- Nursing mother
- History of uncontrolled malignant disease
- Active urogenital infection or chronic infection such as candida, herpes, herpes simplex, bacterial vaginosis, or trichomoniasis
- Immunocompromised conditions including lymphoma, AIDS, or Wiskott-Aldrich syndrome
- Genital skin diseases like psoriasis due to risk of koebnerizing
- Use of immunosuppressant medications such as mycophenolate, retinoids, azathioprine, or cyclosporin
- Known allergy or intolerance to local anesthesia
- Known history of connective tissue disease
- Known tendency for keloid formation
- Medical conditions that may affect wound healing
- Any condition that the investigator believes prevents participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive fractional 2940 nm laser treatment for their lichen sclerosus lesion.
Multiple treatment visits depending on assigned arm
Duration - Up to 16 weeks
Participants are monitored after completion of laser treatment to assess histological clearance and safety.
Follow-up visits scheduled after treatment completion
Trial Site Locations
Total: 1 location
1
Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or, Quebec, Canada, J9P1W1
Actively Recruiting
Research Team
J
J Patel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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