Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT04071756
Status:
TERMINATED
Last Update Posted:
2024-02-07
First Post:
2019-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
A Phase II Randomized Double-Blind Trial of Topical Tazarotene 0.1% Gel Versus Placebo Gel for the Prevention of Regorafenib-Induced Hand-Foot-Skin Reaction
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty with patient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is studying the preventative use of topical 0.1% tazarotene gel daily in addition to best practice standards to reduce the development of hand-foot skin reaction (HFSR).
Detailed Description:
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved tazarotene for specifically for hand-foot skin reaction but it has been approved for other uses.
In this research study, the investigators are:
-aiming to determine if the use of tazarotene gel daily, in addition to best practice standards:
* reduces the development of HFSR.
* decreases modification of regorafenib dose due to HFSR
* improves health-related quality of life associated with HFSR
* decreases stress associated with HFSR
The U.S. Food and Drug Administration (FDA) has not approved tazarotene for specifically for hand-foot skin reaction but it has been approved for other uses.
In this research study, the investigators are:
-aiming to determine if the use of tazarotene gel daily, in addition to best practice standards:
* reduces the development of HFSR.
* decreases modification of regorafenib dose due to HFSR
* improves health-related quality of life associated with HFSR
* decreases stress associated with HFSR
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: