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:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT04711369
Eligibility Criteria:
Inclusion Criteria:
* Women with vulvodynia (diagnosed according to the 2015 Consensus Terminology)
* multidisciplinary treatment for at least 3 months
* Informed consent
Exclusion Criteria:
* Current genital infection (i.e. candidiasis, herpes )
* Inflammatory vulvar disease/ dermatosis (i.e. lichen sclerosus, lichen planus)
* Neoplastic vulvar disease (e.g. HSIL Vulva, Paget disease)
* Recent vulvar trauma (i.e. bleeding, erosion or ulceration)
* Pudendal neuralgia
* Pregnancy, delivery \<6 months
* Epilepsy or major neurologic or psychiatric morbidity
* Active systemic infection
* Previous treatment with ionizing radiation in the area to be treated
* History of wound healing disorders (i.e. hyperpigmentation, abnormal scarring)
* Fever
* Systemic or local autoimmune disorders
* History of photosensitivity disorder
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04711369
Study Brief:
Protocol Section:
NCT04711369