Sorafenib-induced Hand- Foot Skin Reaction Treatment - Full Text View

Purpose

The purpose of this study is to evaluate treatments for a rash caused by sorafenib.

Condition	Intervention	Phase
Hand-foot Skin Reaction Rash	Drug: urea 40% cream Drug: fluocinonide 0.05% cream Drug: tazarotene 0.1% cream Drug: bland emollient cream (Udderly smooth® Udder Cream)	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Four-arm Study to Evaluate Urea 40% Cream, Fluocinonide 0.05% Cream, Tazarotene 0.1% Cream, and an Emollient Cream for the Treatment of Hand-foot Skin Reaction Related to the Use of Multi-targeted Tyrosine Kinase Inhibitor Sorafenib.

Resource links provided by NLM:

MedlinePlus related topics: Foot Health Rashes

Drug Information available for: Carbamide Carbamide peroxide Fluocinonide Tazarotene Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Change in Skindex-16 Total Score Between Baseline and 8 Weeks [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 8 weeks.

Secondary Outcome Measures:

Change in Skindex-16 Total Score Between Baseline and 2 Weeks [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]
The Skindex-16 questionnaire contains 16 questions related to quality of life in patients with skin disease. Total scores may range from 0 to 96, where 0 is associated with a better quality of life and 96 is associated with a worse quality of life. The data provided below indicates the change in the Skindex-16 total score between baseline and at 2 weeks.


Enrollment:	6
Study Start Date:	June 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: urea 40% cream	Drug: urea 40% cream urea 40% cream applied twice per day to affected areas Other Name: carmol 40
Experimental: fluocinonide 0.05% cream	Drug: fluocinonide 0.05% cream fluocinonide 0.05% cream applied twice per day to affected areas
Experimental: tazarotene 0.1% cream	Drug: tazarotene 0.1% cream tazarotene 0.1% cream applied twice per day to affected areas Other Name: tazarac
Experimental: bland emollient cream	Drug: bland emollient cream (Udderly smooth® Udder Cream) bland emollient cream applied twice per day to affected areas Other Name: Udderly smooth® Udder Cream

Detailed Description:

This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
Subjects must be 18 years or older.
Patients must provide written informed consent to participate in the study.
Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria:

Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
Patients with pre-existing dermatological condition affecting the hands or feet.
Women who have a positive pregnancy test or are lactating.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667589

Locations


United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Bayer

Investigators


Principal Investigator:	Dennis West, PhD	Northwestern University

More Information


Responsible Party:	Dennis West, Professor in Dermatology, Northwestern University
ClinicalTrials.gov Identifier:	NCT00667589 History of Changes
Other Study ID Numbers:	STU2149
Study First Received:	April 24, 2008
Results First Received:	February 26, 2013
Last Updated:	May 28, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:


sorafenib rash hand foot skin reaction

Additional relevant MeSH terms:


Sorafenib Tazarotene Nicotinic Acids Emollients Fluocinonide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Dermatologic Agents Keratolytic Agents	Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2016