Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice daily.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cetuximab

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