Hand-foot Skin ReactionPhase 2NCT00667589
Sorafenib-induced Hand- Foot Skin Reaction Treatment
A Phase 2 study testing urea 40% cream, fluocinonide 0.05% cream and tazarotene 0.1% cream in people with Hand-foot Skin Reaction and Rash, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate treatments for a rash caused by sorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand-foot Skin Reaction, Rash
- What is being tested?
- urea 40% cream, fluocinonide 0.05% cream and tazarotene 0.1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
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.
The purpose of this study is to evaluate treatments for a rash caused by sorafenib.
Read the 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.
- Conditions
- Hand-foot Skin Reaction, Rash
- Being tested
- urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, bland emollient cream (Udderly smooth® Udder Cream)
- Keywords
- sorafenib, rash, hand foot skin reaction
- Medical subject headings
- Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urea 40% creamDrug
Also called carmol 40
urea 40% cream applied twice per day to affected areas
fluocinonide 0.05% creamDrug
fluocinonide 0.05% cream applied twice per day to affected areas
tazarotene 0.1% creamDrug
Also called tazarac
tazarotene 0.1% cream applied twice per day to affected areas
bland emollient cream (Udderly smooth® Udder Cream)Drug
Also called Udderly smooth® Udder Cream
bland emollient cream applied twice per day to affected areas
| Study group | Role | What they receive |
|---|---|---|
| urea 40% cream | Experimental | Not described Receives: Drug: urea 40% cream |
| fluocinonide 0.05% cream | Experimental | Not described Receives: Drug: fluocinonide 0.05% cream |
| tazarotene 0.1% cream | Experimental | Not described Receives: Drug: tazarotene 0.1% cream |
| bland emollient cream | Experimental | Not described Receives: Drug: bland emollient cream (Udderly smooth® Udder Cream) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 8 weeks
Secondary outcomes (1)
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.
Measured: baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Study was halted due to poor subject accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hand-foot Skin ReactionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Dennis West, Northwestern University
- Investigators
- Dennis West, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667589
- Sponsor's protocol ID
- STU2149
- Status last verified
- May 2013
- First submitted
- 24 Apr 2008
- Last updated
- 5 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00667589
- Acronym / sponsor ID
- STU2149
- Conditions
- Hand-foot Skin Reaction, Rash
- Keywords
- sorafenib, rash, hand foot skin reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted due to poor subject accrual.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| urea 40% cream | Experimental | Drug: urea 40% cream |
| fluocinonide 0.05% cream | Experimental | Drug: fluocinonide 0.05% cream |
| tazarotene 0.1% cream | Experimental | Drug: tazarotene 0.1% cream |
| bland emollient cream | Experimental | Drug: bland emollient cream (Udderly smooth® Udder Cream) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urea 40% creamAlso: carmol 40urea 40% cream applied twice per day to affected areas | Drug | urea 40% cream |
| fluocinonide 0.05% creamfluocinonide 0.05% cream applied twice per day to affected areas | Drug | fluocinonide 0.05% cream |
| tazarotene 0.1% creamAlso: tazaractazarotene 0.1% cream applied twice per day to affected areas | Drug | tazarotene 0.1% cream |
| bland emollient cream (Udderly smooth® Udder Cream)Also: Udderly smooth® Udder Creambland emollient cream applied twice per day to affected areas | Drug | bland emollient cream |
Primary outcome
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.
1 secondary outcome
Change in Skindex-16 Total Score Between Baseline and 2 Weeks
Time frame: baseline and 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hand-foot Skin Reaction
Recruiting
Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction
Hand-foot Syndrome, Hand-foot Skin Reaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis West, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing urea 40% cream, fluocinonide 0.05% cream and tazarotene 0.1% cream in people with Hand-foot Skin Reaction and Rash, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skindex-16 Total Score Between Baseline and 8 Weeks (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.