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RecruitingNot ApplicableNCT06135402

Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus

Monocentric, Prospective, Randomised, Single Blinded, Active-controlled Trial to Prove That the Treatment With Monalisa Glide is Equal to Topic Clobetasol Propionate Maintenance Therapy in Vulvar Lichen Sclerosus

Sponsor

Kantonsspital Winterthur KSW

Enrollment

120 participants

Start Date

Nov 10, 2023

Study Type

INTERVENTIONAL

Summary

With this trial the investigators look for the effect of Laser maintenance therapy in patients with vulvar lichen sclerosus compared to the maintenance standard treatment clobetasol propionate.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • Pre- or postmenopausal
  • weeks of continuous topical clobetasol treatment completed.
  • Written informed consent
  • German speaking (Study information and IC available only in German)

Exclusion Criteria15

  • Contraindication and limitations for the use of Mona Lisa Glide-Laser as described in the instructions for use
  • Contraindication for the use of topic clobetasol
  • History of vulva laser
  • Immune-suppression
  • Pregnancy or planned pregnancy, breast feeding.
  • Clinically significant concomitant diseases states as severe renal failure, hepatic dysfunction, severe cardiovascular disease, cancer.
  • History of vulvar or pelvic radiation therapy
  • Uncertain vulvar findings, which require a biopsy.
  • Acute vulvitis, especially recurrent genital herpes
  • History of vaginal mesh implantation within 6 months preceding this study
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
  • Previous enrolment into the current investigation
  • Enrolment of the PI, his/her family members, employees and other dependent persons

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Interventions

DEVICETreatment with Monalisa Glide Laser

3 fractional laser treatment-sessions with Monalisa Glide

DRUGTreatment with Clobetasol

Application of Clobetasol twice per week

Locations(1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

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NCT06135402