Sorafenib-induced Hand- Foot Skin Reaction Treatment

Rash Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00667589
• Other study ID #: STU2149
• Status: Terminated
• Phase: Phase 2
• First received: April 24, 2008
• Last updated: May 28, 2013
• Start date: June 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand-foot Skin Reaction
• Rash

Intervention

Drug:
• urea 40% cream
urea 40% cream applied twice per day to affected areas
• 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
• bland emollient cream (Udderly smooth® Udder Cream)
bland emollient cream applied twice per day to affected areas

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and 8 weeks	No
Secondary	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.	baseline and 2 weeks	No