Comparing laser treatment to clobetasol for vulvar 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
This study is testing whether laser treatment can work better than the usual clobetasol cream for people with vulvar lichen sclerosus who have already started treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Kantonsspital Winterthur KSW Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Winterthur, Canton of Zurich) |
| Trial ID | NCT06135402 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of laser maintenance therapy versus standard treatment with clobetasol propionate in patients with vulvar lichen sclerosus. The study aims to assess the impact of fractional CO2-Laser on skin quality and disease management compared to the traditional topical corticosteroid approach. Participants must have completed an initial 12-week treatment with clobetasol and will be randomly assigned to receive either laser treatment or continued clobetasol maintenance. The trial will also evaluate the duration of the laser's therapeutic effects.
Who should consider this trial
Good fit: Ideal candidates are pre- or postmenopausal women who have completed 12 weeks of clobetasol treatment and are German-speaking.
Not a fit: Patients with contraindications for laser treatment or topical clobetasol, as well as those with significant comorbidities, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective long-term treatment option for patients suffering from vulvar lichen sclerosus.
How similar studies have performed: While laser treatment has shown promise in improving vulvovaginal conditions, this specific comparison with clobetasol is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winterthur, Canton of Zurich
- Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Gesine Meili, MD — Clinic of obstetrics and gynecology
- Study coordinator: Rebecca R Zachariah, MD
- Email: rebecca.zachariah@ksw.ch
- Phone: +41522663173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.