Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-29 @ 5:55 PM
Study NCT ID:
NCT01349556
Status:
WITHDRAWN
Last Update Posted:
2014-04-23
First Post:
2011-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin
Status:
WITHDRAWN
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study withdrawn due to volunteer disinterest in participating.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib.
Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash.
Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.
Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash.
Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: