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Study on the Use of Methyl Aminolevulinate and PAGETEX Device for Treating Vulvar Extra-Mammary Paget’s Disease in Women

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What is this study about?

This clinical trial is focused on studying a condition known as Vulvar Extra-Mammary Paget’s Disease, which is a rare skin disorder affecting the vulva. The study will explore the effectiveness and safety of a treatment using a medical device called PAGETEX. This device is used in a process known as photodynamic therapy, which involves using light to activate a special cream applied to the skin. The cream used in this study is called METVIXIA, which contains an active ingredient known as methyl aminolevulinate. This treatment aims to control the disease by reducing or eliminating the affected skin areas.

The purpose of the study is to determine if the PAGETEX device can help control the disease in at least 30% of patients over a period of three months. Participants will apply the METVIXIA cream to the affected area, and the PAGETEX device will be used to deliver light therapy. The study will monitor the response to treatment, including any changes in the size or appearance of the skin lesions. The study will also assess the quality of life, pain levels, and any side effects experienced by participants during the treatment process.

Throughout the study, participants will have regular visits to evaluate their progress. These visits will include assessments by doctors and may involve taking photographs of the affected areas to track changes. The study will last for several months, with key evaluations at three and six months to determine the effectiveness of the treatment. The overall goal is to find a safe and effective way to manage Vulvar Extra-Mammary Paget’s Disease using this innovative approach.

1 joining the study

Upon joining the study, the diagnosis of vulvar extra mammary Paget’s disease must be confirmed by a biopsy conducted within the last year.

Eligibility includes being a woman aged 18 years or older, capable of understanding and providing informed consent, and adhering to the study schedule.

Women of childbearing age must use effective contraception.

2 treatment initiation

The treatment involves the use of METVIXIA 168 mg/g cream, which contains the active substance methyl aminolevulinate.

The cream is applied to the skin (cutaneous use) as part of a photodynamic therapy (PDT) session.

3 photodynamic therapy sessions

During each PDT session, the cream is applied to the affected area.

The presence of PpIX in cancer cells is checked using a dermoscope to confirm the treatment’s effectiveness.

Pain levels during each session are assessed using a visual analog scale from 0 (no pain) to 10 (unbearable pain).

4 follow-up visits

Follow-up visits occur at 3 months and 6 months after treatment initiation.

The disease control rate is assessed by a doctor using photographs of the lesion taken at the start of the study.

Additional assessments include quality of life, sexual life, anxiety, and depression through validated questionnaires.

5 biopsy and erythema assessment

A biopsy is performed on any suspicious lesions at the 3-month and 6-month visits.

The severity of erythema is noted by the doctor using a 4-point scale, and a quantitative measurement is conducted using colorimetry.

6 final evaluation

At the 6-month visit, the overall level of satisfaction with the PDT treatment is measured through a self-questionnaire.

All adverse events are collected and documented from the start of the treatment until the final visit.

Who Can Join the Study?

  • The patient must have non-invasive vulvar Paget’s disease. This means the disease has not spread deeply into the surrounding tissues.
  • The disease can be primary (first occurrence) or recurrent (has come back) after surgical removal.
  • A biopsy confirming the diagnosis must have been done less than one year ago. A biopsy is a small sample of tissue taken from the body to check for disease.
  • The patient must be a woman aged 18 years or older.
  • The patient must be able to understand the study and voluntarily agree to participate by giving informed consent. This means they understand what the study involves and agree to take part.
  • The patient must be able to follow the study visit schedule and meet other study requirements.
  • If the patient is of childbearing age, they must use effective contraception to prevent pregnancy during the study.
  • The patient must have social insurance or be entitled to social security benefits.

Who Cannot Join the Study?

  • Patients who do not have a confirmed diagnosis of Vulvar Extra Mammary Paget’s Disease by a biopsy cannot participate. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined under a microscope.
  • Only female patients are eligible for this study. Male patients cannot participate.
  • Patients who are considered part of a vulnerable population are excluded. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
27.08.2019

Trial locations

Investigated drugs:

PAGETEX is a medical device used as a photodynamic therapy device. It is being studied for its effectiveness and safety in treating Extra-Mammary Paget’s Disease of the Vulva. The device aims to control the disease by achieving stability, partial response, or total response in patients.

Investigated diseases:

Vulvar Extramammary Paget’s Disease – This is a rare skin condition that primarily affects the vulvar region. It is characterized by the presence of Paget cells, which are abnormal cells found in the epidermis. The disease often presents as red, scaly, and itchy patches on the skin, which can sometimes be mistaken for eczema or dermatitis. Over time, these patches may become more pronounced and can lead to discomfort or pain. The progression of the disease can vary, with some cases remaining stable while others may advance to more invasive forms. It is important to monitor the condition closely to assess any changes in the size or nature of the lesions.

Trial ID:
2024-514093-41-00
Protocol code:
2017_71
NCT ID:
NCT03713203
Trial Phase:
Therapeutic exploratory (Phase II)

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