A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI

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.

Completed

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Key information

Conditions

Rash Due to Epidermal Growth Factor Receptor Inhibitors Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

metastatic colon cancer patients
male or female
age> 18
treated EGFRI

Exclusion criteria

prior treatment with EGFRI

Treatment and study plan

RECONVAL CREAM

Drug

Placebo

Drug

Primary outcomes

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

Time frame: 12 weeks

Reduction in numbers of papulo-pustular eruptions in the treatment fields compared to the placebo treated side. Changes in follicular eruptions, dryness/redness of skin estimated by the grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) skin toxicity study group 4.0. Patients own experience of efficacy estimated by questionnaire.

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.

Acronym: EGFRI

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2018
First posted: Jan 8, 2013
Registry last updated: Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed