Sorafenib-induced Hand- Foot Skin Reaction Treatment | NCT00667589

Sorafenib-induced Hand- Foot Skin Reaction Treatment | NCT00667589 | Trialant

Sponsor/Collaborators Module

Name	Class
Bayer	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
urea 40% cream	Experimental	Drug: urea 40% cream
fluocinonide 0.05% cream	Experimental	Drug: fluocinonide 0.05% cream
tazarotene 0.1% cream	Experimental	Drug: tazarotene 0.1% cream
bland emollient cream	Experimental	Drug: bland emollient cream (Udderly smooth® Udder Cream)

Name	Type	Description	Arm Group Labels	Other Names
urea 40% cream	Drug	urea 40% cream applied twice per day to affected areas	urea 40% cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Skindex-16 Total Score Between Baseline and 8 Weeks	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.	baseline and 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Skindex-16 Total Score Between Baseline and 2 Weeks	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.

Contacts/Locations Module

Name	Affiliation	Role
Dennis West, PhD	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University Feinberg School of Medicine, Department of Dermatology		Chicago	Illinois	60611	United States

Arm/Group Information

ID	Title	Description
FG000	Fluocinonide 0.05% Cream	fluocinonide 0.05% cream applied twice per day to affected areas
FG001	Udderly Smooth® Emollient	emollient applied twice per day to affected areas
FG002	Tazarotene 0.1% Cream	tazarotene 0.1% cream applied twice per day to affected areas
FG003	Urea 40% Cream	urea 40% cream applied twice per day to affected areas

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0001 subjects FG0010 subjects FG0023 subjects FG0032 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects
NOT COMPLETED		FG0001 subjects FG0010 subjects FG0023 subjects FG0031 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Fluocinonide 0.05% Cream	fluocinonide 0.05% cream applied twice per day to affected areas
BG001	Udderly Smooth® Emollient	emollient applied twice per day to affected areas

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Categorical			Number

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Skindex-16 Total Score Between Baseline and 8 Weeks

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.

Results for subjects from the fluocinonide 0.05% cream arm, subjects from the Tazarotene 0.1% cream arm, and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not complete a Skindex-16 questionnaire at 8 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.

Posted

Number

units on a scale

baseline and 8 weeks

ID	Title	Description
OG000	Urea 40% Cream	urea 40% cream applied twice per day to affected areas

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fluocinonide 0.05% Cream	fluocinonide 0.05% cream applied twice per day to affected areas

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Hae Bae	Northwestern University	312-695-6829		j-bae@northwestern.edu

ID	Term
D005076	Exanthema

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Intervention Browse Module

ID	Term
D014508	Urea
D005447	Fluocinonide
C086827	tazarotene

ID	Term
D000577	Amides
D009930	Organic Chemicals
D005446	Fluocinolone Acetonide
D011245	Pregnadienes

Secondary

Change in Skindex-16 Total Score Between Baseline and 2 Weeks

Results for one subject from the Tazarotene 0.1% cream arm and one subject from the Urea 40% cream arm are not included in analysis because these subjects did not completed a Skindex-16 questionnaire at 2 weeks. No subjects were randomized to the Udderly Smooth Emollient arm.

Posted

Mean

Standard Deviation

units on a scale

baseline and 2 weeks

ID	Title	Description
OG000	Fluocinonide 0.05% Cream	fluocinonide 0.05% cream applied twice per day to affected areas
OG001	Tazarotene 0.1% Cream	tazarotene 0.1% cream applied twice per day to affected areas
OG002	Urea 40% Cream	urea 40% cream applied twice per day to affected areas

Units	Counts
Participants	OG0001 OG0012 OG0021

Title

Denominators