Hand-foot Skin Reaction, Rash
Conditions
Keywords
sorafenib, rash, hand foot skin reaction
Brief summary
The purpose of this study is to evaluate treatments for a rash caused by sorafenib.
Detailed 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.
Interventions
DRUGurea 40% cream
urea 40% cream applied twice per day to affected areas
fluocinonide 0.05% cream applied twice per day to affected areas
DRUGtazarotene 0.1% cream
tazarotene 0.1% cream applied twice per day to affected areas
DRUGbland emollient cream (Udderly smooth® Udder Cream)
bland emollient cream applied twice per day to affected areas
Sponsors
Bayer
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skindex-16 Total Score Between Baseline and 8 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skindex-16 Total Score Between Baseline and 2 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fluocinonide 0.05% Cream fluocinonide 0.05% cream applied twice per day to affected areas | 1 |
| Udderly Smooth® Emollient emollient applied twice per day to affected areas | 0 |
| Tazarotene 0.1% Cream tazarotene 0.1% cream applied twice per day to affected areas | 3 |
| Urea 40% Cream urea 40% cream applied twice per day to affected areas | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Tazarotene 0.1% Cream | Urea 40% Cream | Fluocinonide 0.05% Cream | Total |
|---|---|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 2 participants | 0 participants | 0 participants | 2 participants |
| Age Categorical Between 18 and 65 years | 1 participants | 2 participants | 1 participants | 4 participants |
| Age Continuous | 63.3 years STANDARD_DEVIATION 12.7 | 60.5 years STANDARD_DEVIATION 3.5 | 61.0 years STANDARD_DEVIATION 0 | 62.0 years STANDARD_DEVIATION 9.3 |
| Gender Female | 2 participants | 2 participants | 0 participants | 4 participants |
| Gender Male | 1 participants | 0 participants | 1 participants | 2 participants |
| Region of Enrollment United States | 3 participants | 2 participants | 1 participants | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1 | 0 / 0 | 0 / 3 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 | 0 / 3 | 0 / 2 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Urea 40% Cream | Change in Skindex-16 Total Score Between Baseline and 8 Weeks | -20 units on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Urea 40% Cream | Change in Skindex-16 Total Score Between Baseline and 2 Weeks | 36 units on a scale | — |
| Tazarotene 0.1% Cream | Change in Skindex-16 Total Score Between Baseline and 2 Weeks | -9.5 units on a scale | Standard Deviation 12 |
| Urea 40% Cream | Change in Skindex-16 Total Score Between Baseline and 2 Weeks | 1 units on a scale | — |