A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis

Accord Healthcare Ltd0 个研究点目标入组 650 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or non-pregnant, non-lactating female of any ethnic group, 18 â?? 70 years of age (both inclusive) at the time of signing the informed consent.
•2.Patients having atopic dermatitis according to Hanifin and Rajka diagnostic criteria (Appendix I).
•3.Patients with a grading of moderate to severe AD (i.e. a score of at least 4.5) as defined by the scoring system of Rajka and Langeland (Appendix II).
•4.Non-immunocompromised adults who have failed to respond adequately to other topical prescription treatments for AD, or when those treatments are not advisable in the opinion of the Investigator.
•5.Last application of medicated topical agents, intake of systemic antihistamines, intranasal or inhaled corticosteroids ( > 1 mg/day) should be minimum 7 days prior to randomization.
•6.Last application of tacrolimus ointment, intake of systemic corticosteroids and nonsteroidal immunosuppressants should be minimum 3 weeks prior to randomization.

•1.Newly diagnosed or Treatment naÃ¯ve patients
•2.Patients with mild (Rajka and Langeland score of < 4.5) or very severe atopic dermatitis that requires systemic therapy
•1.Patients in need of undergoing UV treatments for AD.
•2.Clinically infected atopic dermatitis at the baseline visit

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