Phase
Condition
N/ATreatment
Fractional 2940 nm Laser
Clinical Study ID
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 beforeenrollment
Absence of vulvovaginal infection i.e. fungi, bacterial vaginosis, and STI
Ability to understand and sign informed consent, questionnaires, and allinvestigation 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
Exclusion Criteria:
Pregnancy, less than 3 months postpartum, or planning to become pregnant during theinvestigation 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, herpessimplex, 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
Connect with a study center
Clinique Medicale Uro-Gyneco de l'Abitibi
Val-d'Or, Quebec J9P1W1
CanadaActive - Recruiting
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