A Randomized, Double-Blind Placebo-Controlled Exploration of a Topical Menadione-Containing Lotion to the Face for Prevention and Palliation of Epidermal Growth Factor Receptor Inhibitor-Induced Cutaneous Discomfort and Psychological Distress

Inclusion Criteria:

- Age 18 years or older.

- Patient scheduled to start an epidermal growth factor receptor inhibitor (must be one
of these three: panitumumab, erlotinib, cetuximab) within the next 3 days or patient
has already started the epidermal growth factor receptor inhibitor but has not been
on it for longer than 3 days and has no signs or symptoms potentially suggestive of
EGFR inhibitor toxicity.

- Ability to reliably apply Menadione Topical Lotion / placebo twice a day to the face.

- Ability to complete questionnaire(s) by themselves or with assistance.

- Negative pregnancy test (serum or urine) done ≤ 7 days prior to registration, for
women of childbearing potential only.

- Willing to have photographs taken to assess rash.

Exclusion Criteria:

- Any active facial and/or chest rash, including adult acne, at the time of
randomization.

- Cutaneous metastases, skin cancer, or a history of precancerous skin lesions
involving the face and/or chest.

- Use of topical corticosteroids on the face and/or chest at the time of study entry or
their anticipated use in the next 8 weeks.

- Any type of ongoing therapy for rash.

- Any of the following:

- Pregnant women

- Nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception since this study involves agents that have known genotoxic,
mutagenic and teratogenic effects

- Use of any antibiotic at the time of study or their anticipated use in the 8 weeks
immediately following study enrollment.