NCT02385188|CompletedPhase 3
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Sponsor study identifier
interventional
25
1 country
7
Study Start
May 2015
Actual (reported)Primary Completion
March 2018
Actual (reported)Study Completion
November 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 5, 2015
Actual (reported)March 11, 2015
Actual (reported)May 2015
Actual (reported)March 2018
Actual (reported)November 2019
Actual (reported)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.
12 weeks after the end of treatment
Tolerability questionnaire
4, 10 and 16 weeks after the start of treatment
Adverse events
4, 10 and 16 weeks after the start of treatment
Immunological response
Baseline, 4 and 28 weeks after start of treatment
Quality of life: general.
Baseline, 4 and 28 weeks after start of treatment.
Quality of life: dermatology specific.
Baseline, 4 and 28 weeks after start of treatment.
Topical 5% imiquimod cream will be applicated to the vulvar skin lesion 3 times a week during 16 weeks.
Netherlands Cancer Institute
Amsterdam, 1066CX, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, 5623 EJ, Netherlands
University Medical Center Groningen
Groningen, 9700RB, Netherlands
Leiden University Medical Center
Leiden, 2333ZA, Netherlands
Radboudumc
Nijmegen, 6525HB, Netherlands
Erasmus Medical Center
Rotterdam, 3000CA, Netherlands
University Medical Centre Utrecht
Utrecht, 3584 CX, Netherlands
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.
Joanne de Hullu, MD PhD
Radboud University Medical Center
25 participants (actual enrollment reported by the registry).
First Submitted
February 5, 2015
First Posted
March 11, 2015
Study Start
May 2015
Actual (reported)Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
Contact the study team to confirm eligibility.
Primary Completion
March 2018
Actual (reported)Study Completion
November 2019
Actual (reported)Last Updated
January 2, 2020
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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