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

November 12, 2020 updated by: Per Pfeiffer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Per Pfeiffer

Investigators

  • Principal Investigator: Jesper G. Eriksen, MD, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

March 26, 2010

First Posted (Estimate)

March 29, 2010

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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