Recruiting NCT06389071
Laser Treatment for Lichen Sclerosus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fractional 2940 nm Laser.
- Who it may be relevant to
- Registry conditions: Lichen Sclerosus Lesion. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion
Overview
Fractional ablative laser treatment for Lichen Sclerosus lesion
Interventions
- Device Fractional 2940 nm Laser
Fractional 2940 nm Laser
Primary outcome measures
- Histological clearance [Time frame: 16 weeks]
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:
- Dryness
- Itching
- Burning
- Bleeding
- Blistering
- Soreness
- Easily bruises
- Easily tears
- Ulcerated lesions
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Clinique Medicale Uro-Gyneco de l'Abitibi — Val-d'Or
Identifiers
NCT: NCT06389071 · PLS001