Genital erosive lichen planus
Conditions
Interventions
Trade Name: Otezla
Product Name: apremilast
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - >18 years of age - Female - Moderate to severe GELP at inclusion with the diagnosis based on characteristic clinical and/or histological features. Minimum GELP score 5/30 in vagina and/or vulva (scored separately), of which erythema and pain =1 are mandatory - Informed consent from the patient to the protocol and clinical procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Patients receiving other systemic immune modulating therapy - Concomitant use of strong CYP3A4 enzyme inducers - Inadequate birth control, pregnancy and/or breast-feeding - Depression and suicidal ideation - Patients with severe renal impairment - Patients with active tuberculosis, serious infections or cancer - Unexplained and clinically significant weight loss in underweight patients - Hypersensitivity to the active substance(s) or to any of the excipients - Participating in another trial that might affect the current study or there should be minimum 90 days between participation in another intervention trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of apremilast treatment on GELP ; Secondary Objective: - To assess quality of life and sexual function in women with GELP before and during apremilast treatment - To describe immunohistochemical changes in GELP lesions after treatment with apremilast ;Primary end point(s): Mean GELP score at week 16 in apremilast-treated patients versus placebo-treated patients;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 0, 4, 16 and 32; Secondary end point(s): • Mean GELP score improvement from week 0 to week 32 in all patients • Weekly use of topical steroid, collected from patient diary • Weekly VAS pain score, collected from patient diary • Number of patients with GELP score improvement at week 16 and 32. • Separate GELP score assessments: Area of involvement (in cm2), number of erosions, erythema, striae and pain (VAS) at week 4, 16 and 32 • Physician Global Assessment (PGA) and Patient Global Assessment (PtGA) scores at week 0, 16 and 32 • Selected QoL measures (DLQI, GHQ-28) at week 0, 16 and 32 • Sexual function assessments (FSDS-R) at week 0, 16 and 32 • Description of immune histochemical changes and expression of selected cytokines before and after apremilast therapy, assessed in vulvar or vaginal biopsies at week 0 and 16 • Description of immune histochemical findings in oral biopsies at baseline (week 0) • Immunological markers before and after apremilast therapy, assessed in blood samples collected at week 0 and 16 • Assessment of extragenital lichen planus at week 0, 16 and 32 • Evaluation of clinical photos taken at week 0 and week 32 • Adverse events | — |
Countries
Norway
Contacts
Public Contactas B.5.1
Oslo University Hospital, Norwegian National Advisory Unit on Women's Health
Outcome results
None listed