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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763307
First Posted: January 8, 2013
Last Update Posted: January 8, 2013
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.
Information provided by (Responsible Party):
Hadassah Medical Organization
  Purpose

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 Intervention Phase
Rash Due to Epidermal Growth Factor Receptor Inhibitors Drug: RECONVAL CREAM Drug: PLACEBO Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RECONVAL CREAM
half face treated with RECONVAL CREAM
Drug: RECONVAL CREAM
Placebo Comparator: PLACEBO
half face treated with PLACEBO cream
Drug: PLACEBO

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • prior treatment with EGFRI
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01763307


Contacts
Contact: Hadas` Lemberg, PHD LLB +972 2 6776095 lhadas@hadassah.org.il

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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01763307     History of Changes
Other Study ID Numbers: EGFRI-MER-1a-HMO-CTIL
First Submitted: December 24, 2012
First Posted: January 8, 2013
Last Update Posted: January 8, 2013
Last Verified: December 2012

Keywords provided by Hadassah Medical Organization:
EGFRI
COLON CANCER
SKIN TOXICITY
RECONVAL K1 cream