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RecruitingNot ApplicableNCT06389071

Laser Treatment for Lichen Sclerosus

Safety and Efficacy of Ablative Fractional 2940 nm Laser Treatment for Lichen Sclerosus Lesion

Sponsor

Sciton

Enrollment

50 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Lichen Sclerosus Lesion

Summary

Fractional ablative laser treatment for Lichen Sclerosus lesion

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria19

  • 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 Criteria12

  • 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

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Interventions

DEVICEFractional 2940 nm Laser

Fractional 2940 nm Laser

Locations(1)

Clinique Medicale Uro-Gyneco de l'Abitibi

Val-d'Or, Quebec, Canada

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NCT06389071