Laser therapy compared to treatment with Dermovate ointment for vulvar lichen sclerosus
Zusammenfassung der Studie
In lichen sclerosus, a standard medication therapy with a corticosteroid ointment is performed to prevent further progression of the disease and to alleviate symptoms. In our research project, we want to find out whether laser therapy is equally effective or better than the standard therapy. To this end, half of the participants will receive laser treatment and the other half will receive standard treatment with the corticosteroid ointment. Group assignment will be done randomly. The study provides for nine consultations for each group, spread over one year.
(BASEC)
Untersuchte Intervention
The laser therapy is performed three times at monthly intervals. The laser used is a product already approved in Switzerland. The corticosteroid ointment is applied twice weekly throughout the study period. Photos will be taken at control appointments and you will need to answer questionnaires about your symptoms and your current quality of life.
(BASEC)
Untersuchte Krankheit(en)
Lichen sclerosus
(BASEC)
Clinical diagnosis of lichen sclerosus 3 months of therapy with daily Clobetasol completed Women over 18 years old (BASEC)
Ausschlusskriterien
Contraindications for the use of the Monalisa Glide laser according to manufacturer specifications Contraindications for the use of Clobetasol Previous vulvar laser treatment (BASEC)
Studienstandort
Winterthur
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
Clinic of obstetrics and gynecology,
+41522663173;+41522663173
laura.perotto@clutterksw.ch(ICTRP)
Wissenschaftliche Auskünfte
Clinic of obstetrics and gynecology,
+41522663173;+41522663173
laura.perotto@clutterksw.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
26.09.2023
(BASEC)
ICTRP Studien-ID
NCT06135402 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus (ICTRP)
Untersuchte Krankheit(en)
Lichen Sclerosus (ICTRP)
Untersuchte Intervention
Device: Treatment with Monalisa Glide Laser;Drug: Treatment with Clobetasol (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
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
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Lichen Score (ICTRP)
Lichen Score Follow up;Vulva assessment Scale;German Pelvic floor questionnaire (ICTRP)
Registrierungsdatum
24.10.2023 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Gesine Meili, MD;Rebecca R Zachariah, MD;Rebecca Zachariah, MD, rebecca.zachariah@ksw.ch, +41522663173;+41522663173, Clinic of obstetrics and gynecology, (ICTRP)
Sekundäre IDs
Laser-Lichen (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06135402 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar