Sorafenib-induced Hand- Foot Skin Reaction Treatment
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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
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 6 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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. |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |
Arm | Intervention/treatment |
---|---|
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 |
- Change in Skindex-16 Total Score Between Baseline and 8 Weeks [ Time Frame: 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.
- Change in Skindex-16 Total Score Between Baseline and 2 Weeks [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667589
United States, Illinois | |
Northwestern University Feinberg School of Medicine, Department of Dermatology | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Dennis West, PhD | Northwestern University |
Responsible Party: | Dennis West, Professor in Dermatology, Northwestern University |
ClinicalTrials.gov Identifier: | NCT00667589 |
Other Study ID Numbers: |
STU2149 |
First Posted: | April 28, 2008 Key Record Dates |
Results First Posted: | May 27, 2013 |
Last Update Posted: | June 5, 2013 |
Last Verified: | May 2013 |
sorafenib rash hand foot skin reaction |
Fluocinonide Tazarotene Emollients Dermatologic Agents Keratolytic Agents Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Allergic Agents |