Laser therapy compared to treatment with Dermovate ointment for vulvar lichen sclerosus
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Lichen sclerosus
(BASEC)
Clinical diagnosis of lichen sclerosus 3 months of therapy with daily Clobetasol completed Women over 18 years old (BASEC)
Criteri di esclusione
Contraindications for the use of the Monalisa Glide laser according to manufacturer specifications Contraindications for the use of Clobetasol Previous vulvar laser treatment (BASEC)
Luogo dello studio
Winterthur
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Laura Perotto
+41522662726
laura.perotto@clutterksw.ch(BASEC)
Informazioni generali
Clinic of obstetrics and gynecology,
+41522663173;+41522663173
laura.perotto@clutterksw.ch(ICTRP)
Informazioni scientifiche
Clinic of obstetrics and gynecology,
+41522663173;+41522663173
laura.perotto@clutterksw.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
26.09.2023
(BASEC)
ID di studio ICTRP
NCT06135402 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
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)
Titolo pubblico
Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus (ICTRP)
Malattie studiate
Lichen Sclerosus (ICTRP)
Intervento studiato
Device: Treatment with Monalisa Glide Laser;Drug: Treatment with Clobetasol (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Lichen Score (ICTRP)
Lichen Score Follow up;Vulva assessment Scale;German Pelvic floor questionnaire (ICTRP)
Data di registrazione
24.10.2023 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Gesine Meili, MD;Rebecca R Zachariah, MD;Rebecca Zachariah, MD, rebecca.zachariah@ksw.ch, +41522663173;+41522663173, Clinic of obstetrics and gynecology, (ICTRP)
ID secondari
Laser-Lichen (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06135402 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile