NCT04071756

Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumor
• Hand-Foot Skin Reaction (HFSR)

Interventions

Type	Name	Description
DRUG	Topical Tazarotene	This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin
OTHER	Placebo	A substance that has no therapeutic effect, used as a control in testing new drugs

Timeline

• Start date: 2019-12-30
• Primary completion: 2021-06-12
• Completion: 2022-07-14
• First posted: 2019-08-28
• Last updated: 2024-02-07
• Results posted: 2023-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study