RecruitingNot ApplicableNCT03713203

PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).

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)

Sponsor

University Hospital, Lille

Enrollment

24 participants

Start Date

Aug 27, 2019

Study Type

INTERVENTIONAL

Conditions

Paget Disease of the Vulva Paget Disease, Extramammary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a light-based treatment called photodynamic therapy (PDT) using a device called PAGETEX for patients with a rare skin condition of the vulva called extramammary Paget's disease — a non-invasive cancer-like condition — that has come back after surgery. **You may be eligible if...** - You have been diagnosed with non-invasive extramammary Paget's disease of the vulva (confirmed by biopsy within the past year) that has come back after surgery - Your disease is non-invasive (has not grown into deeper tissues) - You are able to use effective contraception if you are of childbearing age **You may NOT be eligible if...** - Your Paget's disease has grown into deeper tissues (invasive) - You have an underlying adenocarcinoma (a specific type of invasive cancer) - You are sensitive to light or have a condition like porphyria that makes light treatment dangerous - You have received imiquimod cream, photodynamic therapy, or light-sensitizing agents in the past 3 months - You have HIV or have had an organ transplant - You are allergic to the cream ingredients or to peanuts/soy (due to peanut oil in the medication) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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