Vulval erosive lichen planus MedDRA version: 16.1 Level: LLT Classification code 10047727 Term: Vulva disorder System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Prednisolone
Product Name: Prednisolone
Product Code: N/A
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the addition of systemic therapies are better than topical treatment (in conjunction with a short course of oral corticosteroids) in treating patients with ELPV that has not responded to standard first-line topical therapy. The trial will be statistically powered to assess whether the additional systemic therapy is more effective than the control treatment, it will not be powered to assess which of the three additional therapies is the most effective.;Secondary Objective: To assess the tolerability of the systemic therapies in patients with ELPV.; Primary end point(s): Proportion of patients achieving treatment success at 6 months; Treatment success is a composite measure comprising: a)Patient Global Assessment of 0 or 1 on a 4-point scale; b)Investigator Global Assessment of improvement from baseline judged by clinical images A patient should be classed as a success on (a) and (b) to be deemed a treatment success overall. ;Timepoint(s) of evaluation of this end point: This primary endpoint will be assessed 6 months after the comencing the trial treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: This secondary endpoints will be assessed 6 months after the comencing the trial treatment.; Secondary end point(s): 1.Reduction in pain/soreness 2.Global assessment of disease assessed through: a.Patient Global Assessment b.Investigator Global Assessment by treating clinician c.Investigator Global Assessment by blinded assessor using clinical images 3.Assessment of other affected mucosal sites by treating clinician 4.Psychological assessment using the Hospital Anxiety and Depression Scale 5.Assessment of sexual function 6.Health-related quality of life –using a.‘Skindex-29’ b.‘Short Form 36’ 7.Days of topical steroid use during treatment period 8.Treatment satisfaction – assessed as overall satisfaction plus number of patients continuing treatment post the primary endpoint 9.Adverse events (AEs) reported during the study, and discontinuation of medications due to AEs 10.Average cost of intervention in each treatment group per participant | — |
Countries
United Kingdom
Contacts
Public ContactCI
Kim Thomas
Outcome results
None listed