Actively Recruiting
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Led by University Hospital, Lille · Updated on 2026-05-05
24
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Lille
Lead Sponsor
G
Galderma R&D
Collaborating Sponsor
AI-Summary
What this Trial Is About
Vulvar Paget's disease is a rare skin tumour which affect Caucasian post-menopausal women. The disease is revealed by erythematous, eczematous, pruritus and vulvar burns. The diagnosis is often late (from a few months to several years) because the symptoms are neglected by patients or misinterpreted by doctors. The reference treatment is based on surgical excision but unfortunately local recurrences are very frequent (17 to 38% of cases). Photodynamic therapy (PDT) is already used in some dermatological pathologies and could therefore be an alternative treatment. The objective of this study is to assess the efficacy and evaluate the safety of the new PDT device "PAGETEX" for the treatment of vulvar Paget's disease.
CONDITIONS
Official Title
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with non-invasive, primary or recurrent vulvar Paget's disease after surgical resection
- Ability to give informed consent
- Ability to follow the study protocol
- Biopsy-proven recurrent extra mammary Paget's disease within the past year
- Use of effective contraception for women who can become pregnant
You will not qualify if you...
- Invasive vulvar Paget's disease
- Underlying adenocarcinoma
- Photosensitive disorders or reactions
- Treatment with Imiquimod or Aldara 5% cream in the last 3 months
- Photodynamic therapy on lesions within the last 3 months
- Use of photosensitive agents in the last 3 months
- Use of experimental drugs within 30 days before the study
- Allergy or hypersensitivity to methyl aminolevulinate, peanut, or related ingredients
- Porphyria
- Topical corticosteroid treatment on affected area in the last 3 months
- Immunity disorders such as HIV or organ transplantation
- Inability to attend clinical follow-up for psychological, social, or geographical reasons
- Legal incapacity
- Pregnancy or breastfeeding
- Refusal to participate or sign consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital Claude Huriez, CHU
Lille, France
Actively Recruiting
Research Team
L
Laurent Mortier, MD,PhD
CONTACT
S
Serge Mordon, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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