An open label, prospective, randomized, comparative, multi centre, clinical study comparing the efficacy and safety of herbavate vs. conventional therapy in the management of Palmoplantar Keratoderma.

Troikaa Pharmaceuticals Limited0 个研究点目标入组 150 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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•18 years of age or older.
•Clinical diagnosis of isolated (simple) palmoplantar keratoderma involving greter than or equal to 50 percent of the surface of involved acral areas.
•Be generally healthy as determined by brief medical history.
•Be capable of understanding and signing the consent form.

•Have keratoderma associated with malignancy infection or systemic disease.
•Drug or toxin induced keratoderma when patient cannot avoid exposure to drug or toxin.
•PPK involving grater than 50 percent of the surface of involved acral areas.
•Have had therapy with potent topical corticosteroids within one month prior to enrollment;
•Have used systemic treatment with oral retinoids, corticosteroids, or with PUVA within the 8 week period prior to the beginning of the study;
•Are pregnant or lactating, or women not using highly effective contraception;
•Current participation in any other interventional clinical trial;
•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;
•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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