A Randomised Controlled Trial of Adjunctive Systemic Therapy for Vulval Erosive Lichen Planus - HELP trial (systemic tHerapy for vulval Erosive Lichen Planus)

niversity of Nottingham0 个研究点目标入组 20 人开始时间: 2014年4月3日最近更新: 2019年6月30日

研究概览

暂无简介。

•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

•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

发起方

niversity of Nottingham