Topical Gel for Acne-like Skin Issues from Cancer Treatment

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Lutris Pharma Ltd.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a special gel applied regularly for a few weeks to help cancer patients with specific skin rashes from their treatment. The gel aims to reduce and soothe these rashes.

Eligibility Criteria

This trial is for adults with metastatic colorectal cancer (mCRC) who are currently being treated with certain FDA-approved EGFRI drugs and have developed Grade 2 or non-infected Grade 3 acneiform lesions. Participants should be able to apply the gel themselves or have someone to help, not have other cancers within the last three years, and women must test negative for pregnancy.

Inclusion Criteria

Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0)

I am currently receiving an FDA-approved monoclonal antibody treatment for my colorectal cancer.

I have been diagnosed with metastatic colorectal cancer.

+6 more

Exclusion Criteria

Any condition which, in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study

I don't have major skin conditions except for acne-like rashes from cancer treatment.

I do not have a beard that would interfere with the study.

+13 more

Participant Groups

The study tests two different doses of LUT014 Gel against a placebo in mCRC patients with specific skin lesions from EGFRI treatment. The gels are applied daily for four weeks to see if they reduce these skin issues better than a placebo.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: LUT014 Gel (Dose 2)Experimental Treatment1 Intervention

Group II: LUT014 Gel (Dose 1)Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention