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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01094444
First received: February 22, 2010
Last updated: June 15, 2010
Last verified: February 2010
  Purpose

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
Folliculitis
Other: Vitamin K3
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: May 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: January 2012 (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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094444

Contacts
Contact: Per Pfeiffer, Professor, MD, PhD +45 6541 2921 per.pfeiffer@ouh.regionsyddanmark.dk
Contact: Jesper Grau Eriksen, MD +45 jesper@oncology.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense C, Denmark, 5000
Contact: Jesper G. Eriksen, MD       jesper@oncology.dk   
Contact: Per Pfeiffer, professor, MD, PhD    +45 6541 2921    per.pfeiffer@ouh.regionsyddanmark.dk   
Principal Investigator: Jesper G. Eriksen, MD         
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Jesper G. Eriksen, MD Odense University Hospital
  More Information

No publications provided

Responsible Party: Professor Per Pfeiffer, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01094444     History of Changes
Other Study ID Numbers: 09.15
Study First Received: February 22, 2010
Last Updated: June 15, 2010
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Folliculitis
Hair Diseases
Skin Diseases
Vitamin K 3
Vitamin K
Vitamins
Cetuximab
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014