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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 von Hametum® Wund- und Heilsalbe bei Patienten mit arzneimittelinduzierten Hautsymptomen. Eine offene Phase IV – Studie] - Hametum® Wund- und Heilsalbe bei Hautsymptomen durch Arzneimittelnebenwirkungen

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 von Hametum® Wund- und Heilsalbe bei Patienten mit arzneimittelinduzierten Hautsymptomen. Eine offene Phase IV – Studie] - Hametum® Wund- und Heilsalbe bei Hautsymptomen durch Arzneimittelnebenwirkungen

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005624-13-DE
Enrollment
100
Registered
2006-08-29
Start date
2006-03-15
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with drug induced skin symptoms

Interventions

Pharmaceutical Form: Ointment INN or Proposed INN: Hamamelis virginia L., Distillate of leaves and twigs Other descriptive name: Hametum® Wund- und Heilsalbe Concentration unit: g gram(s) Concentratio

Sponsors

Dr. Willmar Schwabe GmbH & Co. KG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of treatment effect (and safety) of Hametum® Wund- und Heilsalbe in patients with drug induced skin symptoms;Secondary Objective: ;Primary end point(s): Sebumetry (lipid content of skin) Corneometry (moisture content of skin)—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026