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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
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.
Sharon Merims, MD
Hadassah Medcial Organization
Israel: Israeli Health Ministry Pharmaceutical Administration