A randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, safety, tolerability and efficacy of omiganan BID in patients with mild to moderate atopic dermatitis

Cutanea Life Sciences0 个研究点目标入组 80 人开始时间: 2016年12月1日最近更新: 2018年2月5日

适应症

试验速览

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•1.Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
•2.AD diagnosis confirmed;
•3.Symptoms present for at least 1 year;
•4.EASI between 7.1 - 50.0, inclusive at screening;
•5.2-20% body surface area (BSA) affected at screening;
•6.Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
•7.Able to participate and willing to give written informed consent and to comply with the study restrictions;
•8.Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.
•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 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Any current and / or recurrent clinical significant skin condition other than AD;
•2.Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
•3.Ongoing use of prohibited atopic dermatitis treatments. Washout periods prior to baseline (first dose of the study drug) are as follows:
•a.Cyclosporine/oral steroids/azathioprine/mycophenolate mofetil/other systemic immunosuppressants: 4 weeks
•b.Phototherapy: 3 weeks
•c.Biologics: 5 half-lives of the drug
•d.Topical calcineurin-inhibitors: 10 days;
•4.Use of topical medication (prescription or over-the-counter [OTC]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
•5.Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
•6.Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
•7.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
•8.Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening;

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