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 Arzneimittelnebenwirkunge
- Conditions
- Patients with drug induced skin symptoms
- Registration Number
- EUCTR2005-005624-13-DE
- Lead Sponsor
- Dr. Willmar Schwabe GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method