A phase 2b, double-blind, randomised, 5-arm, vehicle-controlled, dose-ranging trial to evaluate the efficacy and safety of twice daily topical application of delgocitinib cream 1, 3, 8, and 20 mg/g for 16 weeks in adult subjects with mild to severe chronic hand eczema

EO Pharma A/S0 个研究点目标入组 250 人2018年10月3日

概览

暂无简介。

注册库

who.int

开始日期

2018年10月3日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

EO Pharma A/S

•Age 18 years or above.
•Diagnosis of chronic hand eczema defined as hand eczema, which has persisted for more than 3 months or returned twice or more within the last 12 months.
•Disease severity graded as mild to severe according to IGA (i.e., IGA \=2\).
•Recent history (within 1 year before the screening visit) of inadequate response to topical corticosteroid treatment or topical corticosteroid treatment being medically inadvisable.
•Diagnostic patch testing performed within 3 years prior to the screening visit.
•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 237
•F.1\.3 Elderly (\>\=65 years) yes

•Concurrent skin diseases on the hands, e.g. tinea manuum.
•Active atopic dermatitis in regions other than the hands or psoriasis requiring medical treatment.
•Clinically significant infection (e.g., impetiginised hand eczema) on the hands.
•Systemic treatment with immunosuppressive drugs (e.g., methotrexate, cyclosporine, azathioprine), immunomodulating drugs (e.g., janus kinase inhibitors), retinoids (e.g., alitretinoin), or corticosteroids within 4 weeks prior to baseline (inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for asthma or rhinitis may be used).
•Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks prior to baseline.
•Receipt of live attenuated vaccines 4 weeks prior to baseline.
•Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase\-4 (PDE\-4\) inhibitors, pimecrolimus, tacrolimus) or topical corticosteroids on the hands within 2 weeks prior to baseline.
•Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to baseline.
•Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e., subjects must not start antihistamine treatment or change the current dosage regime within 2 weeks prior to baseline.
•Other cutaneously applied therapy on the hands (except for the use of subject’s own emollients) within 1 week prior to baseline.