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New treatment option for Lichen Sclerosus
Official title Comparison of Laser Treatment With Clobetasol Therapy in Patients With Lichen Sclerosus
ClinicalTrials.gov ID: NCT06135402
What this study is testing
What is Treatment with Clobetasol?
Treatment with Clobetasol is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for lichen sclerosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pre- or postmenopausal
- 12 weeks of continuous topical clobetasol treatment completed.
- Written informed consent
- German speaking (Study information and IC available only in German)
You likely can't join if
- 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.
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Winterthur, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winterthur, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.