Placebo-controlled trial investigating the effect of Vitamin K3-lotion for the treatment of cetuximab induced folliculitis - Vitamin K3

Active, not recruiting

• Conditions: Cancer patients experiencing folliculitis due to treatment with cetuximab; MedDRA version: 12.0Level: LLTClassification code 10061451Term: Colorectal cancer; MedDRA version: 12.0Level: LLTClassification code 10067821Term: Head and neck cancer

• Registration Number: EUCTR2009-016591-68-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-11
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

- Planned or ongoing treatment with cetuximab.
- Age at least 18 years old.
- Informed consent according to local and national legislation
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

Exclusion Criteria

- No known disease which can influence treatment, evaluation and the outcome of the current disease and treatment - including chronic diseases of the skin
- No known hypersensitivity to menadion.
- No concomitant treatment with Vitamin K or Vitamin K-antagonists
- No present psychological, familily, sociological or geographical conditions, which potentially could prevent compliance with the conditions of the protocol and follow-up
- No pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified