Paget Disease, ExtramammaryPhase 3NCT02385188
Topical 5% Imiquimod Cream for Vulvar Paget's Disease
A Phase 3 study testing Imiquimod, paracetamol and lidocaine in Vaseline ointment in people with Paget Disease, Extramammary, run by University Medical Center Nijmegen at 7 sites in Netherlands.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Paget Disease, Extramammary
- What is being tested?
- Imiquimod, paracetamol and lidocaine in Vaseline ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesNetherlands
- Study dates
- May 2015to Nov 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-invasive vulvar Paget's disease, primary or recurrence after earlier surgery;
- Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines.
Who cannot join
- Invasive vulvar Paget's disease;
- Underlying adenocarcinoma;
- Treatment of the vulva with topical 5% imiquimod cream during the last 6 months;
- Participation in a study with another investigational product within 30 days prior to enrolment in this study;
- Hypersensitivity to any component of topical 5% imiquimod cream (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetylalcohol, atearylalcohol);
- Patients with autoimmune disorders;
Show all 10Show fewer
- Immune compromised patients (e.g. HIV patients, patients with a history of transplantation);
- Insufficient understanding of the Dutch or English language;
- Pregnant women;
- Lactating women.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Netherlands7 sites
Netherlands Cancer Institute
Amsterdam, 1066CX
Catharina Ziekenhuis Eindhoven
Eindhoven, 5623 EJ
University Medical Center Groningen
Groningen, 9700RB
Leiden University Medical Center
Leiden, 2333ZA
Radboudumc
Nijmegen, 6525HB
Erasmus Medical Center
Rotterdam, 3000CA
University Medical Centre Utrecht
Utrecht, 3584 CX
About this study
Official title: Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response
The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.
Read the detailed description
Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.
The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.
- Conditions
- Paget Disease, Extramammary
- Being tested
- Imiquimod, paracetamol, lidocaine in Vaseline ointment
- Keywords
- Extramammary Paget's disease, Vulva, Genital, female, imiquimod
- 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.
ImiquimodDrug
Also called Aldara
topical 5% imiquimod cream 3 times a week for 16 weeks.
paracetamolDrug
lidocaine in Vaseline ointmentDrug
| Study group | Role | What they receive |
|---|---|---|
| Imiquimod | Experimental | Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks. Receives: Drug: Imiquimod; Drug: paracetamol; Drug: lidocaine in Vaseline ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.
Measured: 12 weeks after the end of treatment
Secondary outcomes (6)
Tolerability questionnaire
Tolerability will be assessed in a descriptive manner with a tolerability questionnaire with the following questions:
- Have you used paracetamol during treatment?
- How many days?
- What dosage?
- Was the use sufficient?
- Have you used lidocaine in Vaseline ointment during treatment?
- How many days?
- What dosage?
- Was the use sufficient?
- Have you stopped the treatment with imiquimod because of side effects/pain?
Measured: 4, 10 and 16 weeks after the start of treatment
Adverse events
Most common adverse events will be evaluated with the following questions:
- Have you been nauseous? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
- Have you had a head ache? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
- Have you felt more tired than you normally are? No / a little (less than 3 days per week) / severe (more than 3 days a week) / Yes, daily.
Measured: 4, 10 and 16 weeks after the start of treatment
Immunological response
Vulvar skin biopsies will be taken at baseline, 4 and 28 weeks after the start of
Measured: Baseline, 4 and 28 weeks after start of treatment
Quality of life: general.
The questionnaire EQ5D (EuroQOL 5 Dimensions questionnaire) will be used.
Measured: Baseline, 4 and 28 weeks after start of treatment.
Quality of life: dermatology specific.
The questionnaire DLQI (Dermatology Life Quality Index) will be used.
Measured: Baseline, 4 and 28 weeks after start of treatment.
Quality of life: sexuality.
The questionnaire FSDS (Female Sexual Distress Scale) will be used.
Measured: Baseline, 4 and 28 weeks after start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Paget Disease, ExtramammaryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Nijmegen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, University Medical Center Groningen, Erasmus Medical Center, The Netherlands Cancer Institute, UMC Utrecht, Catharina Ziekenhuis Eindhoven
- Responsible party
- Principal investigator, Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen
- Investigators
- Joanne de Hullu, MD PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385188
- Sponsor's protocol ID
- NL51648.091.14
- Status last verified
- Dec 2019
- First submitted
- 5 Feb 2015
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Linden M, van Hees CL, van Beurden M, Bulten J, van Dorst EB, Esajas MD, Meeuwis KA, Boll D, van Poelgeest MI, de Hullu JA. The Paget Trial: topical 5% imiquimod cream for noninvasive vulvar Paget disease. Am J Obstet Gynecol. 2022 Aug;227(2):250.e1-250.e8. doi: 10.1016/j.ajog.2022.04.012. Epub 2022 Apr 18.
PubMed 35447145van der Linden M, Meeuwis K, van Hees C, van Dorst E, Bulten J, Bosse T, IntHout J, Boll D, Slangen B, van Seters M, van Beurden M, van Poelgeest M, de Hullu J. The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease. JMIR Res Protoc. 2017 Sep 6;6(9):e178. doi: 10.2196/resprot.7503.
PubMed 28877863
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response
- ClinicalTrials.gov ID
- NCT02385188
- Acronym / sponsor ID
- NL51648.091.14
- Conditions
- Paget Disease, Extramammary
- Keywords
- Extramammary Paget's disease, Vulva, Genital, female, imiquimod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Medical Center NijmegenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, University Medical Center Groningen, Erasmus Medical Center, The Netherlands Cancer Institute, UMC Utrecht, Catharina Ziekenhuis Eindhoven
- Study start
- May 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 11 Mar 2015 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.
Detailed description
Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.
The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imiquimod | Experimental | Drug: Imiquimod, Drug: paracetamol, Drug: lidocaine in Vaseline ointmentTopical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-invasive vulvar Paget's disease, primary or recurrence after earlier surgery;
- Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines.
Key exclusion criteria (10 listed)
- Invasive vulvar Paget's disease;
- Underlying adenocarcinoma;
- Treatment of the vulva with topical 5% imiquimod cream during the last 6 months;
- Participation in a study with another investigational product within 30 days prior to enrolment in this study;
- Hypersensitivity to any component of topical 5% imiquimod cream (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetylalcohol, atearylalcohol);
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 |
|---|---|---|
| ImiquimodAlso: Aldaratopical 5% imiquimod cream 3 times a week for 16 weeks. | Drug | Imiquimod |
| paracetamol | Drug | Imiquimod |
| lidocaine in Vaseline ointment | Drug | Imiquimod |
Primary outcome
Clinical response
Time frame: 12 weeks after the end of treatment
Clinical response will be assessed by vulvar examination and measurement and is defined as complete remission, partial remission (decrease by ≥50% of total lesion size) or no remission.
6 secondary outcomes
Tolerability questionnaire
Time frame: 4, 10 and 16 weeks after the start of treatment
Adverse events
Time frame: 4, 10 and 16 weeks after the start of treatment
Immunological response
Time frame: Baseline, 4 and 28 weeks after start of treatment
Quality of life: general.
Time frame: Baseline, 4 and 28 weeks after start of treatment.
Quality of life: dermatology specific.
Time frame: Baseline, 4 and 28 weeks after start of treatment.
Quality of life: sexuality.
Time frame: Baseline, 4 and 28 weeks after start of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 35447145van der Linden M, van Hees CL, van Beurden M, Bulten J, van Dorst EB, Esajas MD, Meeuwis KA, Boll D, van Poelgeest MI, de Hullu JA. The Paget Trial: topical 5% imiquimod cream for noninvasive vulvar Paget disease. Am J Obstet Gynecol. 2022 Aug;227(2):250.e1-250.e8. doi: 10.1016/j.ajog.2022.04.012. Epub 2022 Apr 18.
- Derived from this study: PubMed 28877863van der Linden M, Meeuwis K, van Hees C, van Dorst E, Bulten J, Bosse T, IntHout J, Boll D, Slangen B, van Seters M, van Beurden M, van Poelgeest M, de Hullu J. The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease. JMIR Res Protoc. 2017 Sep 6;6(9):e178. doi: 10.2196/resprot.7503.
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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. This study is not recruiting at the moment.
Joanne de Hullu, MD PhD principal investigator
Radboud University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imiquimod, paracetamol and lidocaine in Vaseline ointment in people with Paget Disease, Extramammary, run by University Medical Center Nijmegen at 7 sites in Netherlands.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: 12 weeks after the end of treatment). 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 NCT02385188, which also lists 2 linked publications.
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 2 Jan 2020.