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Trial record 41 of 51 for:    tazarotene

Sorafenib-induced Hand- Foot Skin Reaction Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00667589
Recruitment Status : Terminated (Study was halted due to poor subject accrual.)
First Posted : April 28, 2008
Results First Posted : May 27, 2013
Last Update Posted : June 5, 2013
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Dennis West, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hand-foot Skin Reaction
Rash
Interventions Drug: urea 40% cream
Drug: fluocinonide 0.05% cream
Drug: tazarotene 0.1% cream
Drug: bland emollient cream (Udderly smooth® Udder Cream)
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluocinonide 0.05% Cream Udderly Smooth® Emollient Tazarotene 0.1% Cream Urea 40% Cream
Hide Arm/Group Description fluocinonide 0.05% cream applied twice per day to affected areas emollient applied twice per day to affected areas tazarotene 0.1% cream applied twice per day to affected areas urea 40% cream applied twice per day to affected areas
Period Title: Overall Study
Started 1 0 3 2
Completed 0 0 0 1
Not Completed 1 0 3 1
Arm/Group Title Fluocinonide 0.05% Cream Udderly Smooth® Emollient Tazarotene 0.1% Cream Urea 40% Cream Total
Hide Arm/Group Description fluocinonide 0.05% cream applied twice per day to affected areas emollient applied twice per day to affected areas tazarotene 0.1% cream applied twice per day to affected areas urea 40% cream applied twice per day to affected areas Total of all reporting groups
Overall Number of Baseline Participants 1 0 3 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 3 participants 2 participants 6 participants
<=18 years 0 0 0 0
Between 18 and 65 years 1 1 2 4
>=65 years 0 2 0 2
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 3 participants 2 participants 6 participants
61.0  (0) 63.3  (12.7) 60.5  (3.5) 62.0  (9.3)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 3 participants 2 participants 6 participants
Female 0 2 2 4
Male 1 1 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 3 participants 2 participants 6 participants
1 3 2 6
1.Primary Outcome
Title Change in Skindex-16 Total Score Between Baseline and 8 Weeks
Hide Description 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.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Urea 40% Cream
Hide Arm/Group Description:
urea 40% cream applied twice per day to affected areas
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: units on a scale
-20
2.Secondary Outcome
Title Change in Skindex-16 Total Score Between Baseline and 2 Weeks
Hide Description 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.
Time Frame baseline and 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Fluocinonide 0.05% Cream Tazarotene 0.1% Cream Urea 40% Cream
Hide Arm/Group Description:
fluocinonide 0.05% cream applied twice per day to affected areas
tazarotene 0.1% cream applied twice per day to affected areas
urea 40% cream applied twice per day to affected areas
Overall Number of Participants Analyzed 1 2 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
36 -9.5  (12.0) 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluocinonide 0.05% Cream Udderly Smooth® Emollient Tazarotene 0.1% Cream Urea 40% Cream
Hide Arm/Group Description fluocinonide 0.05% cream applied twice per day to affected areas emollient applied twice per day to affected areas tazarotene 0.1% cream applied twice per day to affected areas urea 40% cream applied twice per day to affected areas
All-Cause Mortality
Fluocinonide 0.05% Cream Udderly Smooth® Emollient Tazarotene 0.1% Cream Urea 40% Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluocinonide 0.05% Cream Udderly Smooth® Emollient Tazarotene 0.1% Cream Urea 40% Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0   0/3 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluocinonide 0.05% Cream Udderly Smooth® Emollient Tazarotene 0.1% Cream Urea 40% Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0   0/3 (0.00%)   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hae Bae
Organization: Northwestern University
Phone: 312-695-6829
EMail: j-bae@northwestern.edu
Layout table for additonal information
Responsible Party: Dennis West, Northwestern University
ClinicalTrials.gov Identifier: NCT00667589     History of Changes
Other Study ID Numbers: STU2149
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: February 26, 2013
Results First Posted: May 27, 2013
Last Update Posted: June 5, 2013