A trial investigating the use of Veregen (EPIgallocatechin-3-gallate) in the treatment of Vulval Intraepithelial Neoplasia

ISRCTN	ISRCTN98495886
DOI	https://doi.org/10.1186/ISRCTN98495886
EudraCT/CTIS number	2013-003107-19
Secondary identifying numbers	15759

Submission date: 17/12/2013
Registration date: 17/12/2013
Last edited: 11/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/trials/a-trial-veregen-cream-vulva-intraepithelial-neoplasia-epivin

Contact information

Miss Baljit Kaur
Scientific

Cancer Research UK Clinical Trials Unit
School of Cancer Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	b.kaur@bham.ac.uk

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Phase II clinical trial investigating the use of EPIgallocatechin-3-gallate (Veregen) in the treatment of Vulval Intraepithelial Neoplasia
Study acronym	EPIVIN
Study objectives	The aim of this early phase trial is to determine if Veregen is a tolerable treatment with a level of activity that warrants further investigation in a definitive phase III trial. The trial will include women with histological diagnosis of VIN3 (usual type) and who have not received any prior treatment in the preceding 4 weeks. The primary objective objective of the trial is to determine whether topical application of epigallocatechin-3-gallate (Veregen) can induce histological resolution of VIN when assessed 32 weeks following the start of treatment. The secondary objectives of the trial are to supplement the primary outcome with analyses of objective response, patient safety, drug compliance and acceptability, need for further treatment, and quality of life. More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15759
Ethics approval(s)	NRES Committee East Midlands - Derby, 20/12/2013, ref: 13/EM/0398
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Vulva
Intervention	1. Experimental arm, Veregen 10% 2. Placebo Study Entry: Single Randomisation only
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Epigallocatechin-3-gallate (Veregen)
Primary outcome measure	Primary Outcome; Timepoint(s): 32 weeks
Secondary outcome measures	Secondary outcome measures; Timepoint(s): 2, 4, 8, 16, 32 and 52 weeks
Overall study start date	01/01/2014
Completion date	30/11/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 56; UK Sample Size: 56
Total final enrolment	26
Key inclusion criteria	1. Female ≥ 18 years of age 2. Histological confirmation of 'usual' type vulval intraepithelial neoplasia (VIN3)* 3. At least one lesion that can be accurately measured (using the RECIST 1.1 criteria) in at least one dimension with longest diameter ≥ 20 mm 4. Using a reliable method of contraception (excluding condoms) 5. Written informed consent to participate in the trial * All histological material generated by this study will be assessed by Specialist Consultant in Gynaecological Pathology, 10% of biopsies will be independently reviewed by a second pathologist
Key exclusion criteria	1. Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease 2. Pregnant, breastfeeding or trying to conceive 3. Treated for VIN within the previous four weeks 4. Known allergy to Veregen or any of its components 5. Patients suffering from immunosuppressive disorder or taking immunosuppressives 6. Unable to comply with the protocol
Date of first enrolment	01/01/2014
Date of final enrolment	10/05/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cancer Research UK Clinical Trials Unit

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	01/09/2020
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal by around 30/11/2019.
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results			28/05/2020	No	No
Results article	results	08/11/2020	18/11/2020	Yes	No
Plain English results		04/11/2021	11/11/2021	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

11/11/2021: Link to plain English results added.
18/11/2020: Publication reference added.
28/05/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
07/05/2020: The intention to publish date was changed from 30/11/2019 to 01/09/2020.
17/01/2018: The following changes were made:
1. The recruitment end date was changed from 01/01/2017 to 10/05/2017.
2. The overall trial end date was changed from 01/01/2017 to 30/11/2018.
3. Publication plan, intention to publish date and participant level data were added.