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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01763307
Recruitment Status : Unknown
Verified December 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 8, 2013
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Rash Due to Epidermal Growth Factor Receptor Inhibitors Drug: RECONVAL CREAM Drug: PLACEBO Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Vitamin K

Arm Intervention/treatment
Experimental: RECONVAL CREAM
half face treated with RECONVAL CREAM
Placebo Comparator: PLACEBO
half face treated with PLACEBO cream

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • prior treatment with EGFRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01763307

Contact: Hadas` Lemberg, PHD LLB +972 2 6776095

Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Sharon Merims, MD Hadassah Medcial Organization

Responsible Party: Hadassah Medical Organization Identifier: NCT01763307     History of Changes
Other Study ID Numbers: EGFRI-MER-1a-HMO-CTIL
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: December 2012

Keywords provided by Hadassah Medical Organization: