A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI (EGFRI)
February 28, 2024 updated by: Hadassah Medical Organization
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.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- metastatic colon cancer patients
- male or female
- age> 18
- treated EGFRI
Exclusion Criteria:
- prior treatment with EGFRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RECONVAL CREAM
half face treated with RECONVAL CREAM
|
|
|
Placebo Comparator: PLACEBO
half face treated with PLACEBO cream
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sharon Merims, MD, Hadassah Medcial Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
December 24, 2012
First Submitted That Met QC Criteria
January 7, 2013
First Posted (Estimated)
January 8, 2013
Study Record Updates
Last Update Posted (Actual)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EGFRI-MER-1a-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.