Ignite Creation Date:
2024-05-05 @ 10:22 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01094444
Status:
COMPLETED
Last Update Posted:
2020-11-16
First Post:
2010-02-22
Brief Title:
Investigation of the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
Sponsor:
Per Pfeiffer
Organization:
Odense University Hospital
Study Overview
Official Title:
Placebo-controlled Trial Investigating the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study aims to explore the benefit of topical vitamin K3 lotion for the reactivationrephosphorylation 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 15 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
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 15 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None