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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT03713203
Eligibility Criteria:
Inclusion Criteria:
* Non-invasive, primary or recurrent vulvar Paget's disease after surgical resection
* Ability to give informed consent.
* Ability to adhere to the study protocol
* Patients must have biopsy (\< 1year) proven recurrent extra mammary Paget's disease
* Effective contraception for Women of childbearing potential
Exclusion Criteria:
* Invasive vulvar Paget's Disease
* Underlying adenocarcinoma
* Subject to photosensitive disorders / reactions
* Treatment with Imiquimod / Aldara 5% cream in the last 3 months
* Photodynamic therapy used to treat MPV lesions in the last 3 months
* Use of photosensitive agents in the last 3 months
* Treatment with an experimental drug in the 30 days prior to the start of the study,
* Allergic or hypersensitivity to methyl aminolevulinate or any of the other ingredients of this medication (propyl p-hydroxybenzoate, cetostearyl alcohol, methyl p-hydroxybenzoate)
* Allergic or hypersensitivity to peanut or soya due to the presence of peanut oil in Metvixia®
* Patient with Porphyria
* Patient already treated with topical corticosteroids on the injured area in the last 3 months
* Patients with immunity disorders (HIV, transplantation)
* Clinical follow-up impossible for psychological, family, social or geographical reasons,
* Legal incapacity
* Pregnant or lactating woman
* Refuse to participate in or sign the consent of the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03713203
Study Brief:
Protocol Section:
NCT03713203