Paget Disease of the VulvaPAGETEXNCT03713203
PAGETEX® Photodynamic Therapy Device for the Treatment of Extra Mammary Paget's Disease of the Vulva (EMPV).
A study testing pagetex PDT in people with Paget Disease of the Vulva and Paget Disease, Extramammary, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Paget Disease of the Vulva, Paget Disease, Extramammary
- What is being tested?
- pagetex PDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 27 Aug 2019to 27 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serge Mordon, MD,PhD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Claude Huriez, CHU
Lille
Laurent Mortier, MD,PhD
About this study
Official title: 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)
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.
- Being tested
- pagetex PDT
- Keywords
- Photodynamic Therapy (PDT), Medical Device, Paget Disease, Metvixia®
- Medical subject headings
- Paget Disease, Extramammary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pagetex PDTDevice
2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.
| Study group | Role | What they receive |
|---|---|---|
| Pagetex PDT | Experimental | PAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)" Receives: Device: pagetex PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease control rate in 30% of patients included
Clinical response will be assessed by vulvar examination by the investigator and independent medical committee. Measurement is defined as complete remission, partial remission (decrease by >50% of total lesion size), stability ( decrease by <50% of total lesion size )or progression of the disease
Measured: At 3 months
Secondary outcomes (10)
disease control rate in 30% of patients included
Clinical response will be assessed by vulvar examination by the investigator and independent medical committee. Measurement is defined as complete remission, partial remission (decrease by ≥50% of total lesion size), stability ( decrease by <50% of total lesion size )or progression of the disease
Measured: at 6 months
Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain
Visual Analogic Scale Evaluation of pain (0 = no pain to 10= unbearable)
Measured: At session 1 and session 2, spaced 15 day; and at session 3 and session 4 spaced 15 days (sessions 3 ; 4 in case of persistent lesions)
Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures
erythema 4 points scale (0 = no erythema, 3=severe erythema) and Chroma meter CR400 (Konica Minolta) measures
Measured: at 3 months, at 6 months
Presence/absence of Paget cells in vulvar biopsy.
Measured: at 3 months, at 6 months
Change in score Dermatology Life Quality Index (DLQI)
DLQI is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person The scoring of each question is as follows:Very much/A lot/A little/Not at all/Not relevan
Measured: at 3 months, at 6 months
Change in SF 36
Measured: at 3 months, at 6 months
Change in Hospital Anxiety and Depression Scale. (HADS)
Each item on the questionnaire is scored from 0-3
Measured: at 3 months, at 6 months
Change in The Female Sexual Function Index (FSFI)
The FSFI is a brief questionnaire measure of sexual functioning in women. 19 questions scoring as follow : 0 = Did not attempt intercourse ;1 = Almost always or always 2 = Most times (more than half the time);3 = Sometimes (about half the time);4 = A few times (less than half the time); 5 = Almost never or never
Measured: at 3 months, at 6 months
Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs
Measured: at 6 months
number of Adverse Events
Incidence and severity of adverse device effects during the study period
Measured: during the study period, an average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start27 Aug 2019
- Primary completion27 Aug 2026 (estimated)
- Study completion27 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paget Disease of the VulvaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Mortier, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713203
- Sponsor's protocol ID
- 2017_71
- Other IDs
- 2018-A01873-52, 2018-002604-13, 2018
- Acronym
- PAGETEX
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Maire C, Staumont-Salle D, Mordon S, Mortier L. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e15026. doi: 10.2196/15026.
PubMed 31793891
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03713203
- Acronym / sponsor ID
- PAGETEX / 2017_71
- Keywords
- Photodynamic Therapy (PDT), Medical Device, Paget Disease, Metvixia®
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Galderma R&D, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 27 Aug 2026 (estimated)
- Study completion
- 27 Aug 2026 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pagetex PDT | Experimental | Device: pagetex PDTPAGETEX medical device for photodynamic therapy (PDT). Composed of the association: "Laser source + optical fiber + diffuser support incorporating luminous textiles + drug photosensitizer (Metvixia®)" |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pagetex PDT2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat. | Device | Pagetex PDT |
Primary outcome
disease control rate in 30% of patients included
Time frame: At 3 months
Clinical response will be assessed by vulvar examination by the investigator and independent medical committee. Measurement is defined as complete remission, partial remission (decrease by >50% of total lesion size), stability ( decrease by <50% of total lesion size )or progression of the disease
10 secondary outcomes
disease control rate in 30% of patients included
Time frame: at 6 months
Subject discomfort measured during each treatment using a Visual Analogic Scale Evaluation of pain
Time frame: At session 1 and session 2, spaced 15 day; and at session 3 and session 4 spaced 15 days (sessions 3 ; 4 in case of persistent lesions)
Clinical Evolution measured using an erythema 4 points scale and Chroma meter CR400 measures
Time frame: at 3 months, at 6 months
Presence/absence of Paget cells in vulvar biopsy.
Time frame: at 3 months, at 6 months
Change in score Dermatology Life Quality Index (DLQI)
Time frame: at 3 months, at 6 months
Change in SF 36
Time frame: at 3 months, at 6 months
Change in Hospital Anxiety and Depression Scale. (HADS)
Time frame: at 3 months, at 6 months
Change in The Female Sexual Function Index (FSFI)
Time frame: at 3 months, at 6 months
Presence or absence of fluorescence on the Dermoscope Fotofinder® photographs
Time frame: at 6 months
number of Adverse Events
Time frame: during the study period, an average 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 31793891Lecomte F, Thecua E, Ziane L, Deleporte P, Duhamel A, Maire C, Staumont-Salle D, Mordon S, Mortier L. Photodynamic Therapy Using a New Painless Light-Emitting Fabrics Device in the Treatment of Extramammary Paget Disease of the Vulva (the PAGETEX Study): Protocol for an Interventional Efficacy and Safety Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e15026. doi: 10.2196/15026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serge Mordon, MD,PhD contact
Laurent Mortier, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pagetex PDT in people with Paget Disease of the Vulva and Paget Disease, Extramammary, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Mortier, MD,PhD ((0)3 20 44 48 68 ext. +33, laurent.mortier@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control rate in 30% of patients included (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.