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

Study Overview
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Brief Summary
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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.

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

Conditions
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Folliculitis

Intervention / Treatment
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* Other: Vitamin K3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin K3-lotion<br>A lotion containing 1.5 mM Vitamin K3. | Other: Vitamin K3<br>* Lotion containing 1.5 mM Vitamin K3<br>|
| No Intervention: B<br>Standard lotion without Vitamin K3 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential reduction in skin toxicity by vitamin K3 lotion | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin K3 lotion, Cetuximab induced folliculitis