Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT06135402
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06135402
Study Brief:
Protocol Section:
NCT06135402