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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01094444
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : January 21, 2015
Information provided by (Responsible Party):
Per Pfeiffer, Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Folliculitis Other: Vitamin K3 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : May 2010
Primary Completion Date : December 2013
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01094444

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

Responsible Party: Per Pfeiffer, Professor, Odense University Hospital Identifier: NCT01094444     History of Changes
Other Study ID Numbers: 09.15
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Per Pfeiffer, 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