Using a new device to treat vulvar Paget's disease with light therapy
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)
NA · University Hospital, Lille · NCT03713203
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Lille (other) |
| Locations | 1 site (Lille) |
| Trial ID | NCT03713203 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with invasive vulvar Paget's disease or underlying adenocarcinoma will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lille
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Paget Disease of the Vulva, Paget Disease, Extramammary, Photodynamic Therapy, Medical Device, Paget Disease, Metvixia®