Lichen Sclerosus
Conditions
Brief 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.
Detailed description
Vulvar Lichen sclerosus (VLS) is a chronic inflammatory cutaneous disorder, which can lead to scarring, impaired sexual function and malignancy. Gold standard treatment is topical corticosteroids (TCS) initially daily for 12 weeks. To avoid new flourishing of the disease a life-long maintenance treatment 2x/week is later recommended. Fractional CO2-Laser has shown a positive effect on vulvovaginal skin quality with improvement of urogenital atrophy and also lichen sclerosus. This randomised trial compares efficacy of laser treatment to TCS maintenance as well as the duration of the laser effect.
Interventions
DEVICETreatment with Monalisa Glide Laser
3 fractional laser treatment-sessions with Monalisa Glide
DRUGTreatment with Clobetasol
Application of Clobetasol twice per week
Sponsors
Kantonsspital Winterthur KSW
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Monocentric, prospective, randomized, single-blinded, active-controlled
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pre- or postmenopausal * 12 weeks of continuous topical clobetasol treatment completed. * Written informed consent * German speaking (Study information and IC available only in German)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lichen Score | 3 months | The difference between the initial Lichen score and the score at 3 month after treatment start = 1 month after EOT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| German Pelvic floor questionnaire | 15 months | Shortened Pelvic floor questionnaire at 1, 4, 8, 12 months after EOT |
| Lichen Score Follow up | 15 months | Lichen score at 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms) |
| Vulva assessment Scale | 15 months | Vulva assessment scale at 1, 4, 8 and 12 months after EOT, Scale from 0 (no symptoms) to 12 (symptoms) |
Countries
Switzerland
Contacts
Primary ContactRebecca R Zachariah, MD
Backup ContactSusanne Forst
Outcome results
None listed