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.
Rash Due to Epidermal Growth Factor Receptor Inhibitors
Drug: RECONVAL CREAM
|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.|
- 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.
|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)|
Experimental: RECONVAL CREAM
half face treated with RECONVAL CREAM
|Drug: RECONVAL CREAM|
Placebo Comparator: PLACEBO
half face treated with PLACEBO cream
|Contact: Hadas` Lemberg, PHD LLB||+972 2 firstname.lastname@example.org|
|Principal Investigator:||Sharon Merims, MD||Hadassah Medcial Organization|