drugset / Trial / NCT02385188
Topical 5% Imiquimod Cream for Vulvar Paget's Disease
Phase 3
Completed
25 enrolled
University Medical Center Nijmegen
Catharina Ziekenhuis Eindhoven · collabErasmus Medical Center · collabLeiden University Medical Center · collabThe Netherlands Cancer Institute · collabUMC Utrecht · collabUniversity Medical Center Groningen · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-05
- Primary completion
- 2018-03
- Completion
- 2019-11
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.
- van 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imiquimod | Other / unclassified | 5 % | Topical |
| Background | Acetaminophen | Small molecule | — | — |
| Background | Lidocaine | Other / unclassified | — | — |