Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06118047
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-31
Brief Title:
Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Efficacy and Safety of Crisaborole Ointment a Phosphodiesterase 4 PDE4 Inhibitor for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer PatientsA Prospective Single-arm Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSTIC
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None