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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Claude Huriez, CHU
RECRUITING
Lille
Contact Information
Primary
Laurent Mortier, MD,PhD
laurent.mortier@chru-lille.fr
(0)3 20 44 48 68
Backup
Serge Mordon, MD,PhD
serge.mordon@inserm.fr
Time Frame
Start Date: 2019-08-27
Estimated Completion Date: 2026-08-27
Participants
Target number of participants: 24
Treatments
Experimental: Pagetex PDT
PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)
Related Therapeutic Areas
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, Galderma R&D
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov