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Veregen® ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single center randomised control study
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  • Jason Yap,
  • Daniel Slade,
  • Harriet Goddard,
  • Christopher Dawson,
  • Raji Ganesan,
  • Shireen Velangi,
  • Banchhita Sahu,
  • Baljit Kaur,
  • Ana Hughes,
  • David Luesley
Jason Yap
Institute of Cancer and Genomic Sciences
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Daniel Slade
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Harriet Goddard
Sandwell and West Birmingham Hospitals NHS Trust
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Christopher Dawson
University of Warwick
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Raji Ganesan
Birmingham Women's and Children's NHS Foundation Trust
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Shireen Velangi
University Hospitals Birmingham NHS Foundation Trust
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Banchhita Sahu
Princess Royal Hospital
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Baljit Kaur
University of Birmingham
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Ana Hughes
University of Birmingham
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David Luesley
Institute of Cancer and Genomic Sciences
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Abstract

Objective To compare the safety and efficacy of Veregen® ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design A Phase II randomised control trial. Setting A tertiary gynaecological oncology referral center. Population All women diagnosed with primary and recurrence uVIN. Methods Eligible patients were randomised to receive either Veregen® or placebo ointment (applied 3 times daily for 16 weeks), and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures Outcome measures, recorded at 16 and 32 weeks, were histological (HR) and clinical (CR) response (as measured by ≥30% reduction in the sum of the longest diameter of all lesions when compared to baseline), toxicity and changes in quality of life and pain scores. Results 26 patients were randomised and all 13 patients who received Veregen® showed either complete (n=5) or partial (n=8) CR with a trend towards an improvement in baseline symptoms. In placebo group, 3 patients had complete CR, 2 had partial CR and 6 had stable disease. Patients in the Veregen® group showed a significant improvement in CR as compared to the placebo group (P=0.0026). There was no evidence of difference in HR and toxicity reported in both groups. Conclusion Our study indicates that Veregen application is safe and leads to at least a partial clinical resolution of uVIN lesions and symptoms improvement, thus warranting a phase III multi-centre RCT.

Peer review status:IN REVISION

21 Mar 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
23 Mar 2020Submission Checks Completed
23 Mar 2020Assigned to Editor
25 Mar 2020Reviewer(s) Assigned
30 Apr 2020Review(s) Completed, Editorial Evaluation Pending
08 Jun 2020Editorial Decision: Revise Major
28 Jul 20201st Revision Received
31 Jul 2020Assigned to Editor
31 Jul 2020Submission Checks Completed
24 Aug 2020Review(s) Completed, Editorial Evaluation Pending
24 Aug 2020Editorial Decision: Revise Major
07 Sep 20202nd Revision Received
07 Sep 2020Assigned to Editor
07 Sep 2020Submission Checks Completed