Investigation on treatment effect and safety of Hametum® Wund- und Heilsalbe in patients with drug induced skin symptoms. An open phase IV trial [Untersuchung zu Behandlungseffekt und Verträglichkeit vonHametum® Wund- und Heilsalbe bei Patienten mit arzneimittelinduzierten Hautsymptomen. Eine offene Phase IV – Studie] - Hametum® Wund- und Heilsalbe bei Hautsymptomen durch Arzneimittelnebenwirkungen

Dr. Willmar Schwabe GmbH & Co. KG0 个研究点目标入组 100 人开始时间: 2006年8月29日最近更新: 2014年2月10日

试验速览

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•Female and male patients aged = 18 years
•Written consent
•Patients with skin symptoms like skin lesions, dryness. scaling or pruritus which are induced by drug application
•Lipid content of skin < 6 µg Sebum/cm2 skin
•Moisture of skin = 55 arbitrary units
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Hypersensitivity to trial medication
•Large and infected wounds
•Active or infectious skin disease
•Severe diseases, which exclude particpation in the judgement of the investigator
•Drug and / or alcohole abuse
•Application of local drugs or skin care products within 7 days prioir to enrolement or during treatment
•Inadequate willingness to participate
•Removal of hair (e.g. shave, epilation) on the left lower leg 7 days prior to enrolement or during the trial

发起方