Ignite Creation Date:
2024-05-06 @ 2:10 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04239846
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2020-01-21
Brief Title:
Prophylactic Treatment of Skin Rash Associated With EGFR Inhibitor Therapy
Sponsor:
TWi Biotechnology Inc
Organization:
TWi Biotechnology Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Trial of AC-701 for Treatment of Skin Rash in Subjects With EGFR Inhibitor Therapy
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
Epidermal growth factor receptor inhibitor EGFRI therapy for cancer is associated with potentially severe face and trunk skin acneiform rash Severe or persistent side effects may lead to decreased dose interruption or discontinuation of EGFRI treatment Inflammation is believed to play an important role in EGFRI-induced skin toxicity as a number of proinflammatory cytokines induced by EGFRI are released from epidermal cells resulting in activation and recruitment of immune cells such as neutrophils and lymphocytes and subsequent development of skin reaction associated with keratinocyte apoptosis AC-701 has been reported its antibiotic and anti-inflammatory activities in literature and further demonstrated in vitro effect to prevent the secretion of inflammatory cytokines associated with EGFR inhibition This study is to evaluate the prophylactic efficacy of topical AC-701 in subjects with skin rash associated with EGFRI therapy
Detailed Description:
None
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