LUT014 for the Reduction of Dose-Limiting Acneiform Lesions Associated With EGFRI Treatment of mCRC

Inclusion Criteria:

1. Diagnosed with mCRC;
2. Currently being treated with an FDA approved monoclonal antibody EGFRI for thetreatment of mCRC, including but not limited to Erbitux® (cetuximab) Injection andVectibix® (panitumumab) Injection, as directed by the approved labeling;
3. Grade 2 or Grade 3 non-infected acneiform lesions at the Screening and Baseline;
4. A reversed score of no more than 44 for the skin-specific questions (first 13questions) of the FACT-EGFRI-18 HRQoL questionnaire at the Screening and Baseline;
5. Age ≥18 years at the time of signing the informed consent form (ICF);
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;
7. Expected life expectancy greater than 3 months;
8. Subject can understand and sign the ICF, can communicate with the Investigator, canunderstand and comply with the requirements of the protocol, and can apply the studydrug by himself/herself or has a care giver that can apply the drug;
9. Women of childbearing potential (WCBP) must have a negative serum pregnancy test atScreening and a negative urine pregnancy test at Baseline (Day 0);

Exclusion Criteria:

1. Active infection within the treatment area or in other body areas that requiresinitiation of systemic antibiotics ;
2. Significant skin disease other than EGFRI induced acneiform lesions within the samebody areas planned for study drug application;
3. Has a beard that would interfere with administration of study drug and assessment ofstudy endpoints (scoring of lesions);
4. Any cancer other than mCRC within 3 years of Screening, except for carcinoma in situof the cervix;
5. Any condition which, in the opinion of the Investigator, places the subject atunacceptable risk if he/she were to participate in the study;
6. Clinically relevant serious co-morbid medical conditions including, but not limitedto, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension,uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonarydisease, active central nervous system (CNS) disease uncontrolled by standard of care,known positive status for human immunodeficiency virus (HIV) and/or active hepatitis Bor C, cirrhosis, or psychiatric illness/social situations that would limit compliancewith study requirements;
7. Pregnant or lactating;
8. Treatment with an EGFRI other than the FDA approved monoclonal antibody EGFRI for thetreatment of mCRC within 30 days or 5 half-lives of the drug prior to Screening,whichever is longer;
9. Treatment with a serine/threonine-protein kinase B-Raf (B-Raf) inhibitor, includingbut not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), Braftovi® (encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drugprior to Screening, whichever is longer. Patients whose mCRC is being treated with amonoclonal antibody EGFRI in combination with a B-Raf inhibitor, such as Erbitux® (cetuximab) Injection in combination with Braftovi® (encorafenib) Capsules, will notbe eligible to participate in this trial;
10. Treatment with a systemic corticosteroid 14 days prior to Baseline or treatment with atopical corticosteroid to the face, neck, or upper portion of the anterior orposterior chest within 7 days prior to Baseline (Day 0). Patients receiving systemiccorticosteroids for 24 hours or less only at the time of chemotherapy infusions (forthe prevention or treatment of chemotherapy-induced nausea and vomiting) will beallowed to enroll into this study;
11. Treatment with a topical antibiotic to the face, neck, or upper portion of theanterior or posterior chest within 7 days prior to Baseline (Day 0);
12. Initiation of treatment with systemic antibiotic(s) < 28 days prior to Baseline (Day

0. or any change in dose or frequency of systemic antibiotic(s) within 28 days priorto Baseline. Patients that undergo a washout from systemic antibiotic(s) will beallowed to participate in this trial as long as no systemic antibiotics are takenwithin 7 days prior to Baseline and they meet all other eligibility criteria;

13. Treatment with any other topical medication applied to the face, neck, or upperportion of the anterior or posterior chest within 7 days prior to Baseline (Day 0).
14. Treatment with an oral retinoid within 30 days or 5 half-lives of the drug prior toBaseline (Day 0), whichever is longer. Patients that undergo a washout from oralretinoids will be allowed to participate
15. Treatment with another investigational drug within 30 days or 5 half-lives of drugprior to Screening, whichever is longer;
16. Known hypersensitivity to the inactive ingredients of the study drug (active orplacebo).