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Rash Due to Epidermal Growth Factor Receptor Inhibitors | A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI

Rash Due to Epidermal Growth Factor Receptor Inhibitors research study

What is the primary objective of this study?

Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients. This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.

Who is eligible to participate?

Inclusion Criteria: - metastatic colon cancer patients - male or female - age> 18 - treated EGFRI Exclusion Criteria: - prior treatment with EGFRI

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Rash Due to Epidermal Growth Factor Receptor Inhibitors

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:RECONVAL CREAM

Drug:PLACEBO

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

RECONVAL CREAMhalf face treated with RECONVAL CREAM

PLACEBOhalf face treated with PLACEBO cream

Study Status

Unknown status

Start Date: January 2013

Completed Date: December 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Sharon Merims, MD

Lead Sponsor: Hadassah Medical Organization

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01763307

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