Trial Information
Placebo-controlled Trial Investigating the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
Inclusion Criteria:
- Planned or ongoing treatment with cetuximab
- Age at least 18 years
- Informed written consent according to local and national legislation
Exclusion Criteria:
- Known disease that can influence either treatment, evaluation and the outcome of the
current disease and treatment, including chronic dermatology
- Known hypersensitivity to menadion
- Concomitant treatment with Vitamin K or Vitamin K-antagonists
- Known psychological, family, sociological or geographic conditions which potentially
can influence planned study treatment or follow-up
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Potential reduction in skin toxicity by vitamin K3 lotion
Outcome Description:
Reduction in numbers of papulo-pustular eruptions in the treatment fields. Changes in follicular eruptions, dryness/redness of skin estimated by CTCAE 4.0. Patients own experience of efficacy estimated by questionaire and VAS scale.
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Jesper G. Eriksen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Odense University Hospital
Authority:
Denmark: Danish Dataprotection Agency
Study ID:
09.15
NCT ID:
NCT01094444
Start Date:
May 2010
Completion Date:
December 2012
Related Keywords:
- Folliculitis
- Vitamin K3 lotion
- Cetuximab induced folliculitis
- Folliculitis