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New light treatment offers hope for rare vulvar cancer

NCT ID NCT03713203

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device called PAGETEX that uses light therapy (photodynamic therapy) to treat a rare skin condition called vulvar Paget's disease. The disease often comes back after surgery, so researchers want to see if this light treatment can control it better. About 24 women with non-invasive or recurrent disease will receive the treatment, and doctors will check if the lesions shrink or disappear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

extramammary Paget disease vulval Paget disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Paget disease of the vulva Paget disease, extramammary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Claude Huriez, CHU

    RECRUITING

    Lille, France

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