NCT06118047

Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

Efficacy and Safety of Crisaborole Ointment, a Phosphodiesterase 4 (PDE4) Inhibitor, for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer Patients：A Prospective, Single-arm, Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The efficacy of cetuximab has been demonstrated in treating metastatic colorectal cancer (mCRC). Skin toxicities, especially acneiform eruption, are the major side effects associated with cetuximab, which affect patients' quality of life and can lead to treatment discontinuation and cetuximab dose reduction. This prospective, single-arm, phase II clinical trial aims to explore the efficacy and safety of crisaborole ointment in Cetuximab-Related Skin Toxicity. A total of 33 mCRC patients with acneiform eruption will be enrolled. All of the participants will receive crisaborole ointment twice daily. The total follow-up time is 12 weeks.

Conditions

• Metastatic Colorectal Cancer
• Cetuximab
• Skin Toxicity

Interventions

Type	Name	Description
DRUG	Crisaborole Ointment	Crisaborole ointment to be applied twice daily.
DRUG	Cetuximab	Cetuximab

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: China