Laser therapy compared to treatment with Dermovate ointment for vulvar lichen sclerosus
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Lichen sclerosus
(BASEC)
Clinical diagnosis of lichen sclerosus 3 months of therapy with daily Clobetasol completed Women over 18 years old (BASEC)
Critères d'exclusion
Contraindications for the use of the Monalisa Glide laser according to manufacturer specifications Contraindications for the use of Clobetasol Previous vulvar laser treatment (BASEC)
Lieu de l’étude
Winterthur
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. Laura Perotto
+41522662726
laura.perotto@clutterksw.ch(BASEC)
Informations générales
Clinic of obstetrics and gynecology,
+41522663173;+41522663173
laura.perotto@clutterksw.ch(ICTRP)
Informations scientifiques
Clinic of obstetrics and gynecology,
+41522663173;+41522663173
laura.perotto@clutterksw.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
26.09.2023
(BASEC)
Identifiant de l'essai ICTRP
NCT06135402 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
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)
Titre public
Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus (ICTRP)
Maladie en cours d'investigation
Lichen Sclerosus (ICTRP)
Intervention étudiée
Device: Treatment with Monalisa Glide Laser;Drug: Treatment with Clobetasol (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
Lichen Score (ICTRP)
Lichen Score Follow up;Vulva assessment Scale;German Pelvic floor questionnaire (ICTRP)
Date d'enregistrement
24.10.2023 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Gesine Meili, MD;Rebecca R Zachariah, MD;Rebecca Zachariah, MD, rebecca.zachariah@ksw.ch, +41522663173;+41522663173, Clinic of obstetrics and gynecology, (ICTRP)
ID secondaires
Laser-Lichen (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06135402 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible