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 because the information has not been verified recently.
Verified December 2012 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
First received: December 24, 2012
Last updated: January 7, 2013
Last verified: December 2012

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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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
Placebo Comparator: PLACEBO
half face treated with PLACEBO cream


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • prior treatment with EGFRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763307

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

Sponsors and Collaborators
Hadassah Medical Organization
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 
Study First Received: December 24, 2012
Last Updated: January 7, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

ClinicalTrials.gov processed this record on May 23, 2016