An open label, prospective, randomized, comparative, single centre, clinical study comparing the efficacy and safety of Herbavate vs. the conventional steroid therapy in the management of hand dermatitis.

Troikaa Pharmaceuticals Limited0 个研究点目标入组 60 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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•1.18 years of age or older;
•2.Have mild to moderate hand dermatitis, according to the Investigator Global Assessment (score2-3);
•3.Be generally healthy, as determined by brief medical history;
•4.Be capable of understanding and signing the consent form.

•1.Have clinically relevant allergic or irritant contact dermatitis and the inability to avoid exposure;
•2.Have severe dermatitis according to the Investigator Global Assessment (score 4);
•3.Have severe vesiculation or bullae;
•4.Have a history of psoriasis, contact urticaria, and/or pustular diseases;
•5.Have had therapy with potent topical corticosteroids within one month prior to enrollment;
•6.Have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study;
•7.Have a history or current evidence of a chronic or infectious skin disease
•8.Are pregnant or lactating, or women not using highly effective contraception;
•9.Current participation in any other interventional clinical trial;
•10.Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use) within 4 weeks prior to randomisation; and
•11.Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).

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