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Investigation of the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis

This study has been completed.
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital Identifier:
First received: February 22, 2010
Last updated: January 20, 2015
Last verified: January 2015

The study aims to explore the benefit of topical vitamin K3 lotion for the reactivation/rephosphorylation of EGF-receptor in the skin and the possible reduction in cutaneous side effects of EGFr-inhibition.

Primary aim: The possible reduction of cutaneous side effects: folliculitis, dryness and redness of the skin.

Secondary aim: To explore any possible side effects of topical vitamin K3 lotion.

Methods: 36 patients with metastatic colorectal cancer or metastatic head and neck cancer allocated to treatment with chemotherapy and biweekly cetuximab. Two equally sized areas of at least 10x10 cm on the back or chest of the patient is marked. Patients receive in a double blinded procedure placebo lotion on one side and vitamin K3 lotion on the other side. The treatment may last for a maximum of two months and the patients are followed biweekly with photos, VAS-scores, questionnaires and CTCAE estimations. The patient will be able to take weekly photos at home during the weeks they are not seen at the outpatient clinic. During the treatment all other skin products or antibiotics is allowed and will be carefully registered by the health care professionals in the outpatient clinic.

The patient may enter the trial in two different ways: 18 patients start treatment with study lotions at the time they start treatment with cetuximab. The other 18 patients start treatment with study lotions when folliculitis appears.

Patients are asked for 1.5 mm skin biopsies of both study areas of the skin before start of treatment and after 4 weeks of treatment with placebo lotion and vitamin K3 lotion. These biopsies will be investigated for EGFr, phosphorylated EGFr and other central downstream mechanisms. The biopsy part of the study is optional for the patient.

Condition Intervention Phase
Other: Vitamin K3
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-controlled Trial Investigating the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Potential reduction in skin toxicity by vitamin K3 lotion [ Time Frame: 3 months ]
    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.

Secondary Outcome Measures:
  • Potential toxicity of vitamin K3 lotion [ Time Frame: 3 months ]
    No systemic or skin toxicity is expected. Therefore all experienced skin changes will be estimated by CTCAE 4.0. Furthermore, broad bloodtest screenings will be done bi-weekly.

Enrollment: 30
Study Start Date: May 2010
Study Completion Date: November 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin K3-lotion
A lotion containing 1.5 mM Vitamin K3.
Other: Vitamin K3
Lotion containing 1.5 mM Vitamin K3
No Intervention: B
Standard lotion without Vitamin K3


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01094444

Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Per Pfeiffer
Principal Investigator: Jesper G. Eriksen, MD Odense University Hospital
  More Information

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital Identifier: NCT01094444     History of Changes
Other Study ID Numbers: 09.15
Study First Received: February 22, 2010
Last Updated: January 20, 2015

Keywords provided by Odense University Hospital:
Vitamin K3 lotion
Cetuximab induced folliculitis

Additional relevant MeSH terms:
Hair Diseases
Skin Diseases
Vitamin K
Vitamin K 3
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on April 28, 2017