A Phase 2a, 15-Day, Randomized, Parallel Group, Double-Blind, Multi-Centre, Vehicle Controlled Trial to Assess the Efficacy and Local Safety of a Cream Containing 0.5% Roflumilast - a Phosphodiesterase Type 4 Inhibitor (PDE4i) Dermal Formulation – on Atopic Dermatitis Patients with Skin Lesions of Moderate Severity

Takeda Pharma A/S0 个研究点开始时间: 2012年8月14日最近更新: 2014年10月27日

试验速览

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•Subjects aged 18 to 65 with atopic dermatitis according to Hanifin and Rajka’s criteria, with lesional skin areas of moderate severity, characterized by a modified local SCORAD of at least 4, with an erythema score =2 and confirmed by a qualified investigator. Subjects must have a target lesion of approximately 20 cm2, suitable for topical treatment, and be willing to wash out from current active therapy for atopic dermatitis prior to Day 1.
•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 37
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•Subjects who have hypersensitivity to roflumilast or related compounds, a history of atopic dermatitis unresponsive or poorly responsive to topical treatments, a current skin complication such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated, have evidence of oozing at the target lesion, or have used any of the excluded medications within the time frames listed in Excluded Medications and Treatments and in the inclusion and exclusion criteria.

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