Using a new device to treat vulvar Paget's disease with light therapy
Official title: An Interventional, Phase II, Non Randomized, Mono-centric Study on the Clinical Efficacy and Safety of the Medical Device PAGETEX® as a Photodynamic Therapy Device in the Treatment of Extra-Mammary Paget's Disease of the Vulva (EMPV)
Run by University Hospital, Lille · NCT03713203 · Data updated 2026-11-12
This study is testing a new light therapy device to see if it can safely treat vulvar Paget's disease in women who have already had surgery for this rare skin condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 24 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | August 27, 2019 |
| Main results expected | August 27, 2026 |
| Study ends | August 27, 2026 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT03713203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include women with non-invasive, primary or recurrent vulvar Paget's disease who have had a biopsy confirming the diagnosis within the last year.
✕Probably not a fit
Patients with invasive vulvar Paget's disease or underlying adenocarcinoma will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness and safety of the PAGETEX® photodynamic therapy device for treating extra mammary Paget's disease of the vulva, a rare skin tumor primarily affecting post-menopausal Caucasian women. The study focuses on patients with non-invasive, primary or recurrent vulvar Paget's disease who have previously undergone surgical resection. By utilizing photodynamic therapy, which has shown promise in other dermatological conditions, the trial aims to provide an alternative treatment option that may reduce the high rates of local recurrence associated with traditional surgical methods.
Why it matters
Potential benefit: If successful, this treatment could offer a non-invasive alternative for managing vulvar Paget's disease, potentially improving patient outcomes and reducing recurrence rates.
How similar studies have gone: While photodynamic therapy has been used in other dermatological conditions, this specific application for vulvar Paget's disease is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Claude Huriez, CHU
Lille, France Recruiting
Study contacts
- Principal investigator: Laurent Mortier, MD,PhD — University Hospital, Lille
- Study coordinator: Laurent Mortier, MD,PhD
- Email: laurent.mortier@chru-lille.fr
- Phone: (0)3 20 44 48 68
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Treatment for advanced extramammary Paget disease of the scrotum
This study is testing a new combination of two drugs to see if they can help people with advanced HER2-positive extramammary Paget disease of the scrotum feel better and reduce their tumor size.
-
Treatment of rare advanced tumors with a combination of drugs
This study is testing a new combination of drugs to see if it can help people with rare advanced tumors live longer and feel better.
-
Using Ivocizumab to treat various advanced rare tumors
This study is testing if a new treatment called Ivocizumab can help people with different types of advanced rare tumors feel better and live longer.
-
Understanding Extramammary Paget's Disease in Women
This study looks at women with Extramammary Paget's Disease to see how different treatments work and to learn more about the skin and health in those areas.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.