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

NCT01094444 | Completed Phase 2 DMC

• 1 other identifier: 09.15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Folliculitis

Keywords

Vitamin K3 lotion; Cetuximab induced folliculitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Potential toxicity of vitamin K3 lotion

  3 months

Study Arms (2)

Vitamin K3-lotion

EXPERIMENTAL

A lotion containing 1.5 mM Vitamin K3.

Other: Vitamin K3

B

NO INTERVENTION

Standard lotion without Vitamin K3

Interventions

Vitamin K3 OTHER

Lotion containing 1.5 mM Vitamin K3

Vitamin K3-lotion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned or ongoing treatment with cetuximab
• Age at least 18 years
• Informed written consent according to local and national legislation

You may not qualify if:

• 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

Sponsors & Collaborators

• Per Pfeiffer: lead

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (1)

• Eriksen JG, Kaalund I, Clemmensen O, Overgaard J, Pfeiffer P. Placebo-controlled phase II study of vitamin K3 cream for the treatment of cetuximab-induced rash. Support Care Cancer. 2017 Jul;25(7):2179-2185. doi: 10.1007/s00520-017-3623-x. Epub 2017 Feb 15.

  PMID: 28197850 BACKGROUND

MeSH Terms

Conditions

Folliculitis

Interventions

Vitamin K 3

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Jesper G. Eriksen, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: March 29, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: November 1, 2014
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

DK (1)