Clinical trial · Interventional
Topical 5% Imiquimod Cream for Vulvar Paget's Disease
Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response
NCT02385188CI-TRIAL-00042551completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Paget Disease, Extramammary | Extramammary Paget Disease | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| lidocaine in Vaseline ointment | Drug | — | UNRESOLVED |
| paracetamol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imiquimod
- description
- Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
- interventionNames
- Drug: Imiquimod
- Drug: paracetamol
- Drug: lidocaine in Vaseline ointment
Primary outcomes (1)
- measure
- Clinical response
- timeFrame
- 12 weeks after the end of treatment
- description
- 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.
Secondary outcomes (6)
- measure
- Tolerability questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * 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.
References
Publications (2)
- DERIVEDvan 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. PMID 35447145
- DERIVEDvan 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. PMID 28877863