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Placebo-controlled Trial Investigating the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Folliculitis

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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

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