Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

Launched by SUN YAT-SEN UNIVERSITY · Nov 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for skin problems caused by a medication called Cetuximab, which is used for metastatic colorectal cancer. The researchers want to see if applying crisaborole ointment twice a day can help reduce skin toxicity in patients who are experiencing severe skin reactions, such as acne-like rashes, from their cancer treatment. This trial is currently recruiting participants who are 18 years or older and are undergoing treatment with Cetuximab.

To be eligible for the trial, patients must have a specific type of skin reaction that is graded at least a level 2 on a medical scale. They should also be in reasonably good health, meaning their main organs are functioning well, and they have a life expectancy of more than three months. Participants will apply the ointment and attend follow-up visits to monitor their skin condition and overall health. It's important to note that individuals with active skin diseases or those who have had allergic reactions to crisaborole ointment may not qualify for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed mCRC and undergoing Cetuximab treatment;
• • 2. ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0;
• • 3. Age 18 years and older；
• • 4. ECOG performance status 0-2.；
• • 5. Bone marrow ,brain, heart, kidney and other organ function well;；
• • 6. Expected survival time more than 3 months;
• Exclusion Criteria:
• • 1. The presence of any active skin disease；
• • 2. Undergoing any current hormone therapy for any other disease;
• • 3. Prior allergic reaction or severe intolerance to crisaborole ointment