Trial Outcomes & Findings for Sorafenib-induced Hand- Foot Skin Reaction Treatment (NCT NCT00667589)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2013-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Fluocinonide 0.05% Cream fluocinonide 0.05% cream applied twice per day to affected areas	Tazarotene 0.1% Cream tazarotene 0.1% cream applied twice per day to affected areas	Urea 40% Cream urea 40% cream applied twice per day to affected areas
Overall Study STARTED	1	3	2
Overall Study COMPLETED	0	0	1
Overall Study NOT COMPLETED	1	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib-induced Hand- Foot Skin Reaction Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluocinonide 0.05% Cream n=1 Participants fluocinonide 0.05% cream applied twice per day to affected areas	Udderly Smooth® Emollient emollient applied twice per day to affected areas	Tazarotene 0.1% Cream n=3 Participants tazarotene 0.1% cream applied twice per day to affected areas	Urea 40% Cream n=2 Participants urea 40% cream applied twice per day to affected areas	Total n=6 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Age Categorical Between 18 and 65 years	1 participants n=5 Participants	—	1 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants
Age Categorical >=65 years	0 participants n=5 Participants	—	2 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Age Continuous	61.0 years STANDARD_DEVIATION 0 • n=5 Participants	—	63.3 years STANDARD_DEVIATION 12.7 • n=5 Participants	60.5 years STANDARD_DEVIATION 3.5 • n=4 Participants	62.0 years STANDARD_DEVIATION 9.3 • n=21 Participants
Gender Female	0 participants n=5 Participants	—	2 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants
Gender Male	1 participants n=5 Participants	—	1 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	3 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Urea 40% Cream n=1 Participants urea 40% cream applied twice per day to affected areas	Tazarotene 0.1% Cream tazarotene 0.1% cream applied twice per day to affected areas	Urea 40% Cream urea 40% cream applied twice per day to affected areas
Change in Skindex-16 Total Score Between Baseline and 8 Weeks	-20 units on a scale	—	—

SECONDARY outcome

Timeframe: baseline and 2 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Urea 40% Cream n=1 Participants urea 40% cream applied twice per day to affected areas	Tazarotene 0.1% Cream n=2 Participants tazarotene 0.1% cream applied twice per day to affected areas	Urea 40% Cream n=1 Participants urea 40% cream applied twice per day to affected areas
Change in Skindex-16 Total Score Between Baseline and 2 Weeks	36 units on a scale	-9.5 units on a scale Standard Deviation 12.0	1 units on a scale

Adverse Events

Fluocinonide 0.05% Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Udderly Smooth® Emollient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tazarotene 0.1% Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Urea 40% Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hae Bae

Northwestern University

Phone: 312-695-6829

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place