| Exclusion Criteria: | 1) A skin examination reveals the presence of any active disease (e.g., eczema), tattoos or other problems, such as open lesions, that could make that application site unacceptable for study drug lotion application, located on the face/neck and/or upper chest that, in the Investigator's opinion, could confound the evaluation of the rash.
2) Any clinically significant safety laboratory or diagnostic results that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study.
3) Any clinically significant finding or concurrent clinical illness in the physical examination or medical history that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study.
4) Undergoing any current treatment for cancer other than the prescribed EGFRI that in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study.
5) Prior treatment with any marketed or investigational EGFRI therapy within the 3 months prior to screening (Visit 1).
6) Treatment with topical antibiotics, topical steroids, and other topical treatments on the face/neck and/or upper chest within 14 days of first study lotion application.
7) Systemic use of steroids will be stopped at Visit 1 and not allowed during the course of the study.
8) Treatment with vitamin K supplements or multivitamins containing any form of vitamin K should be stopped at Visit 1.
9) Known hypersensitivity to menadione or similar compounds including any of the inactive ingredients
10) Treatment with oral anticoagulants (i.e., Warfarin).
11) Any subjects with prior history of bleeding and hemolytic disorders.
12) Clinically significant abnormal laboratory values at screening, to include but not limited to the following hematologic, renal and liver function laboratory values: a). Hematologic function: Hgb < 9.0 g/dL or < 10.0 g/dL for subjects receiving hematopoietic growth factors, such as darbopoeitin alfa or epoetin alfa, ANC < 500/mm3 (or < 1.5 x 10^9/L), Platelet count < 100,000/mm3 (or < 100 × 10^9/L);[continues in exclusion #13]
13) [Continued from eligibility #12] - b.) Renal function: Serum creatinine > 1.5 mg/dL or > 133 umol/L (SI units) or calculated estimated creatinine clearance < 60 mL/min/1.73 m^2 based on Cockcroft and Gault formula; c.) Hepatic function: Aspartate transaminase (AST) or alanine transaminase (ALT) > 3 x institutional ULN or > 5 X institutional ULN if documented liver metastasis, Total bilirubin > 2 X institutional ULN or > 5 X institutional ULN if documented liver metastasis.
14) Treatment with any cosmetic cream, make-up or products such as sunscreen, oils, powders, perfumes, lotions, ointments, etc. to the anticipated study drug lotion application area within 3 days before treatment or during the treatment period.
15) Known or suspected pregnancy, lactation or planned pregnancy (females and males).
16) Clinically significant mental illness (to be determined by the Investigator).
17) Exposure to any investigational agent within 2 weeks or 3 half lives prior to randomization (Visit 3, Day 1 for Group 1 or Visit 2, Day 1 for Group 2)
18) The subject will be disqualified if they have a rash for longer than 5 days at a grade of 3 or more prior to administration of first menadione dose (per CTCAE v3.0 terminology).
19) Subject has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk. |