Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study

J Yap; D Slade; H Goddard; C Dawson; R Ganesan; S Velangi; B Sahu; B Kaur; A Hughes; D. Luesley

doi:10.1111/1471-0528.16574

Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study

J Yap^*, D Slade, H Goddard, C Dawson, R Ganesan, S Velangi, B Sahu, B Kaur, A Hughes, D. Luesley

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Objective: To compare the safety and efficacy of 10% sinecatechins (Veregen^®) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN).

Design: A Phase II double-blind randomised control trial.

Setting: A tertiary gynaecological oncology referral centre.

Population: All women diagnosed with primary and recurrent uVIN.

Methods: Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied three times daily for 16 weeks) and were followed up at 2, 4, 8, 16, 32 and 52 weeks.

Main outcome measures: The primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores.

Results: There was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n = 5) or partial (n = 8) CR, when best CR was evaluated. In placebo group, three patients had complete CR, two had partial CR, six had stable disease and two were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared with the placebo group (P = 0.002). There was no difference in toxicity reported in either group.

Conclusion: Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study.

Tweetable abstract: A randomised control study indicating that sinecatechins ointment may be a novel treatment for uVIN.

Original language	English
Pages (from-to)	1047-1055
Number of pages	9
Journal	BJOG: An International Journal of Obstetrics and Gynaecology
Volume	128
Issue number	6
Early online date	19 Oct 2020
DOIs	https://doi.org/10.1111/1471-0528.16574
Publication status	Published - May 2021

Bibliographical note

Funding Information:
This study was part funded by Medigene AG, Germany, who supplied 10% sinecatechins ointment (Veregen) and placebo ointment. Medigene AG did not participate in designing or conducting the clinical trial or recruiting patients into the study, nor did it have any input in reporting the study outcome or writing the manuscript. None of the authors have any role in Medigene AG. This report is independent research commissioned by the National Institute for Health Research (Research for Patient Benefit Programme). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. All authors declare no other disclosures. Completed disclosure of interest forms are available to view online as supporting information. ®

Publisher Copyright:
© 2020 John Wiley & Sons Ltd.

Keywords

Epigallocatechin-3-gallate
human papillomavirus
quality of life
vulvar intraepithelial neoplasia

ASJC Scopus subject areas

Obstetrics and Gynaecology

Access to Document

10.1111/1471-0528.16574

Cite this

Yap, J., Slade, D., Goddard, H., Dawson, C., Ganesan, R., Velangi, S., Sahu, B., Kaur, B., Hughes, A., & Luesley, D. (2021). Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study. BJOG: An International Journal of Obstetrics and Gynaecology, 128(6), 1047-1055. https://doi.org/10.1111/1471-0528.16574

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abstract = "Objective: To compare the safety and efficacy of 10% sinecatechins (Veregen{\textregistered}) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design: A Phase II double-blind randomised control trial. Setting: A tertiary gynaecological oncology referral centre. Population: All women diagnosed with primary and recurrent uVIN. Methods: Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied three times daily for 16 weeks) and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures: The primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores. Results: There was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n = 5) or partial (n = 8) CR, when best CR was evaluated. In placebo group, three patients had complete CR, two had partial CR, six had stable disease and two were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared with the placebo group (P = 0.002). There was no difference in toxicity reported in either group. Conclusion: Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study. Tweetable abstract: A randomised control study indicating that sinecatechins ointment may be a novel treatment for uVIN.",

keywords = "Epigallocatechin-3-gallate, human papillomavirus, quality of life, vulvar intraepithelial neoplasia",

author = "J Yap and D Slade and H Goddard and C Dawson and R Ganesan and S Velangi and B Sahu and B Kaur and A Hughes and D. Luesley",

note = "Funding Information: This study was part funded by Medigene AG, Germany, who supplied 10% sinecatechins ointment (Veregen) and placebo ointment. Medigene AG did not participate in designing or conducting the clinical trial or recruiting patients into the study, nor did it have any input in reporting the study outcome or writing the manuscript. None of the authors have any role in Medigene AG. This report is independent research commissioned by the National Institute for Health Research (Research for Patient Benefit Programme). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. All authors declare no other disclosures. Completed disclosure of interest forms are available to view online as supporting information. {\textregistered} Publisher Copyright: {\textcopyright} 2020 John Wiley & Sons Ltd.",

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Yap, J, Slade, D, Goddard, H, Dawson, C, Ganesan, R, Velangi, S, Sahu, B, Kaur, B, Hughes, A & Luesley, D 2021, 'Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 128, no. 6, pp. 1047-1055. https://doi.org/10.1111/1471-0528.16574

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T2 - a single-centre double-blind randomised control study

AU - Yap, J

AU - Slade, D

AU - Goddard, H

AU - Dawson, C

AU - Ganesan, R

AU - Velangi, S

AU - Sahu, B

AU - Kaur, B

AU - Hughes, A

AU - Luesley, D.

N1 - Funding Information: This study was part funded by Medigene AG, Germany, who supplied 10% sinecatechins ointment (Veregen) and placebo ointment. Medigene AG did not participate in designing or conducting the clinical trial or recruiting patients into the study, nor did it have any input in reporting the study outcome or writing the manuscript. None of the authors have any role in Medigene AG. This report is independent research commissioned by the National Institute for Health Research (Research for Patient Benefit Programme). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. All authors declare no other disclosures. Completed disclosure of interest forms are available to view online as supporting information. ® Publisher Copyright: © 2020 John Wiley & Sons Ltd.

PY - 2021/5

Y1 - 2021/5

N2 - Objective: To compare the safety and efficacy of 10% sinecatechins (Veregen®) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design: A Phase II double-blind randomised control trial. Setting: A tertiary gynaecological oncology referral centre. Population: All women diagnosed with primary and recurrent uVIN. Methods: Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied three times daily for 16 weeks) and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures: The primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores. Results: There was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n = 5) or partial (n = 8) CR, when best CR was evaluated. In placebo group, three patients had complete CR, two had partial CR, six had stable disease and two were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared with the placebo group (P = 0.002). There was no difference in toxicity reported in either group. Conclusion: Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study. Tweetable abstract: A randomised control study indicating that sinecatechins ointment may be a novel treatment for uVIN.

AB - Objective: To compare the safety and efficacy of 10% sinecatechins (Veregen®) ointment against placebo in the treatment of usual type vulvar intraepithelial neoplasia (uVIN). Design: A Phase II double-blind randomised control trial. Setting: A tertiary gynaecological oncology referral centre. Population: All women diagnosed with primary and recurrent uVIN. Methods: Eligible patients were randomised 1:1 to receive either sinecatechins or placebo ointment (applied three times daily for 16 weeks) and were followed up at 2, 4, 8, 16, 32 and 52 weeks. Main outcome measures: The primary outcome measure, recorded at 16 and 32 weeks, was histological response (HR). Secondary outcome measures included clinical (CR) response, toxicity, quality of life and pain scores. Results: There was no observed difference in HR between the two arms. However, of the 26 patients who were randomised, all 13 patients who received sinecatechins showed either complete (n = 5) or partial (n = 8) CR, when best CR was evaluated. In placebo group, three patients had complete CR, two had partial CR, six had stable disease and two were lost to follow up. Patients in the sinecatechins group showed a statistically significant improvement in best observed CR as compared with the placebo group (P = 0.002). There was no difference in toxicity reported in either group. Conclusion: Although we did not observe a difference in HR between the two treatment arms, we found that 10% sinecatechins application is safe and shows promise in inducing clinical resolution of uVIN lesions and symptom improvement, thus warranting further investigation in a larger multicentre study. Tweetable abstract: A randomised control study indicating that sinecatechins ointment may be a novel treatment for uVIN.

KW - Epigallocatechin-3-gallate

KW - human papillomavirus

KW - quality of life

KW - vulvar intraepithelial neoplasia

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IS - 6

ER -

Sinecatechins ointment as a potential novel treatment for usual type vulval intraepithelial neoplasia: a single-centre double-blind randomised control study

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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