A trial to investigate the use of Veregen ointment in the treatment of vulval intraepithelial neoplasia, a severe skin disorder that may lead to vulval cancer.

Phase 1

• Conditions: Vulval intraepithelial neoplasia (VIN); MedDRA version: 16.1Level: LLTClassification code 10057313Term: Vulval intraepithelial neoplasia grade IIISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-003107-19-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-11
• Study Completion: 2019-01-08
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

= 18 years of age, histological confirmation of usual-type vulval intraepithelial neoplasia (VIN3)*, 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, using a reliable method of contraception (excluding condoms), 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Suspected anogenital carcinoma or those considered by the attending clinician to be at high risk of developing invasive disease; pregnant, breast feeding or trying to conceive; treated for VIN within the previous four weeks; known allergy to Veregen or any of its components; patients suffering from immunosuppressive disorder or taking immunosuppressives; unable to comply with the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified