Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-03-01
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment + PRP Arm
Fractional 2940 nm Laser
Fractional 2940 nm Laser
Treatment only Arm
Fractional 2940 nm Laser
Fractional 2940 nm Laser
Interventions
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Fractional 2940 nm Laser
Fractional 2940 nm Laser
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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Sciton
INDUSTRY
Responsible Party
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Principal Investigators
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Josee Parent, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Medicale Uro-Gyneco de l'Abitibi
Locations
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Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Josee Parent, MD
Role: primary
Other Identifiers
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PLS001
Identifier Type: -
Identifier Source: org_study_id
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