Investigation of the Effect of Vitamin K3-lotion for the... | NCT01094444

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

NCT01094444

Sponsor

Per Pfeiffer

Status

Completed

Last Update Posted

Nov 16, 2020Actual

Enrollment

30Actual

Phase

Phase 2

Conditions

Folliculitis

Interventions

Vitamin K3

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2013Actual

Completion Date

Nov 2014Actual

First Submitted Date

Feb 22, 2010

First Submission Date that Met QC Criteria

Mar 26, 2010

First Posted Date

Mar 29, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2020

Last Update Posted Date

Nov 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Per Pfeiffer, Professor, Odense University HospitalSponsor-Investigator

Lead Sponsor

Per PfeifferOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin K3-lotion	Experimental	A lotion containing 1.5 mM Vitamin K3.	Other: Vitamin K3
B	No Intervention	Standard lotion without Vitamin K3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin K3	Other	Lotion containing 1.5 mM Vitamin K3	Vitamin K3-lotion

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jesper G. Eriksen, MD	Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense C		5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28197850	Background	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.

ID	Term
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D014812	Vitamin K
D009285	Naphthoquinones
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons