Tablet treatments for Erosive Lichen Planus affecting the vulval area.

Phase 1

• Conditions: Vulval erosive lichen planus; MedDRA version: 16.1 Level: LLT Classification code 10047727 Term: Vulva disorder System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-000547-32-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-03
• Study Completion: 2016-03-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

i.Clinical diagnosis of erosive lichen planus affecting the vulva;

ii.Histological examination within the past 12 months to exclude alternative diagnoses;

iii.Inadequate control despite first-line therapy with clobetasol propionate 0.05%;

iv.Disease severity of moderate-severe on Investigator Global Assessment;

v.Negative microbiological swabs at study entry;

vi.Willing and capable of giving informed consent;

vii.Willing to have clinical images taken;

viii.Age >18 years (there is no upper age limit);

ix.Use of effective contraceptive methods in females of childbearing age.

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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

i.Cases of lichen sclerosus/lichen planus overlap;

ii.Patients taking Beta Blockers or non-steroidal anti-inflammatory medications;

iii.Received one or more of the trial drugs within the last one month (excluding clobetasol propionate 0.05%);

iv.Previous/current diagnosis of malignant disease (skin or internal);

v.Pre-malignant vulval skin or cervical disease;

vi.Receiving concurrent medications that would preclude the use of any of the trial medications in normal practice;

vii.History of clinically significant renal or liver impairment or other pre-existing medical conditions that would preclude the use of any of the trial medications in normal practice;

viii.Administration of a live vaccine (BCG, Measles, Mumps, Rubella, Yellow Fever, Oral Polio, Oral Typhoid) within the last 2 weeks;

ix.Pregnancy or breast-feeding;

x.Known sensitivity to any of the trial medications

Study & Design

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