HFSNCT07501442
Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
A study testing Uracil 0,5% plasters and lenitive cream in people with HFS, run by Wooshin Labottach Co., Ltd. at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn if The Uracil plaster works to treat mild HFS in adults under chemiotherapy. It will also learn about the safety . The main questions it aims to answer are: Does Uracil Plaster lower the number of days participants need to reduce the HFS symptoms? What medical problems do… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HFS
- What is being tested?
- Uracil 0,5% plasters and lenitive cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Both sexes;
- Aged over 18 years;
- Willing and able to return to the study site for post-procedural assessments;
- Agree to take precautions to prevent pregnancy (applicable only to non-menopausal female subjects), including abstinence, intrauterine device (IUD), progestin implants, combined estrogen-progestin contraceptives, or condom use;
- Agree to sign the informed consent form.
- With HFS of grade I and II severity due to chemotherapy Self-sufficient with Performance Status of 0, 1, 2 according with the EOCG table.
- Red blood cells folate test and serum folate test- Independent Biomarkers performed and to polymorphism testing DPD before starting therapy with dihydro pyrimidines.
Who cannot join
- Patients with grade III severity according to of HFS severity (Hand-Foot Syndrome- NCI-CTCAE v.0 Severity Grading.
- ECOG Performance Status Scale = 3 or 4
- Pregnancy (applicable only to non-menopausal female subjects);
- Breastfeeding (applicable only to non-menopausal female subjects);
- Non-menopausal female subjects not using the specified contraceptive measures to prevent pregnancy during the study;
- Sensitivity or allergy to the investigational product or its components (to be assessed by the investigator at baseline);
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- Predicted poor compliance with study protocol;
- Participation in a similar study currently or within the past 3 months;
- Dermatological clinical conditions that could interfere with performance outcomes;
- Current pharmacological treatment with:
- Medications that may affect test results as deemed by the investigator.
- Use of other medications not mentioned above can be authorized by the investigator. Trade name, dosage, start and end dates of therapy will be documented in the concomitant medication form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Presidio Ospedaliero Di Rho - Asst Rhodense- Oncology Department
Rho, MI, 20017
Roberto Bollina, Prof, +393356070900, rbollina@asst-rhodense.it
About this study
Official title: A Randomized, Single Blind, Parallel Groups, Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5%-Containing Plasters Versus "Lenitive Cream", in Oncology Patients Affected by Hand-foot Syndrome (HFS)
The goal of this clinical trial is to learn if The Uracil plaster works to treat mild HFS in adults under chemiotherapy. It will also learn about the safety .
The main questions it aims to answer are:
Read more
Does Uracil Plaster lower the number of days participants need to reduce the HFS symptoms? What medical problems do participants have when using the Uracil plaster MD? Researchers will compare the Uracil plaster to a standard lenitive cream to see if Uracil Plaster works better to treat mild HFS.
Participants will:
Use the plaster or the cream 2/3 times day for 3 weeks Visit the hospital once every week for checkups and tests Keep a diary of their symptoms and the number of times they use the therapy
- Conditions
- HFS
- Being tested
- Uracil 0,5% plasters, lenitive cream
- Keywords
- Uracil, uracil plaster, HFS, HFS in oncologic patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uracil 0,5% plastersDevice
Patients will applicate to hands and feet the plaster twice per day for 3 weeks to reduce the HFS grade.
lenitive creamDevice
Patients will applicate the cream 3 times per day for 3 weeks to compare the change of HFS severity
| Study group | Role | What they receive |
|---|---|---|
| Experimental device | Experimental | Patients will applicate Uracil plasters twice per day for 3 weeks Receives: Device: Uracil 0,5% plasters |
| Lenitive cream | Active comparator | Patients will applicate Lenitive cream 3 times per day for 3 weeks Receives: Device: lenitive cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events number
Number of Adverse events during the treatment
Measured: 3 weeks, from the start to the end of the trial
Complete healing of the lesions according to HFS severity scale
Complete healing of the hands or feet lesions without chemotherapy dosage reduction, using HFS severity scales to assess the absence of symptoms.
Measured: 3 weeks, from beginning to end of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFSStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, two arms (experimental device vs. standard lenitive cream), single blind interventional study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wooshin Labottach Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501442
- Sponsor's protocol ID
- 2025/AFCV/WOOSHIN/UPT/ONR/09
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The trial results will be published on scientific paper
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Parallel Groups, Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5%-Containing Plasters Versus "Lenitive Cream", in Oncology Patients Affected by Hand-foot Syndrome (HFS)
- ClinicalTrials.gov ID
- NCT07501442
- Acronym / sponsor ID
- 2025/AFCV/WOOSHIN/UPT/ONR/09
- Conditions
- HFS
- Keywords
- Uracil, uracil plaster, HFS, HFS in oncologic patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wooshin Labottach Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nextrasearch S.r.l.s.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if The Uracil plaster works to treat mild HFS in adults under chemiotherapy. It will also learn about the safety .
The main questions it aims to answer are:
Does Uracil Plaster lower the number of days participants need to reduce the HFS symptoms? What medical problems do participants have when using the Uracil plaster MD? Researchers will compare the Uracil plaster to a standard lenitive cream to see if Uracil Plaster works better to treat mild HFS.
Participants will:
Use the plaster or the cream 2/3 times day for 3 weeks Visit the hospital once every week for checkups and tests Keep a diary of their symptoms and the number of times they use the therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monocentric, two arms (experimental device vs. standard lenitive cream), single blind interventional study
| Arm | Type | Receives |
|---|---|---|
| Experimental device | Experimental | Device: Uracil 0,5% plastersPatients will applicate Uracil plasters twice per day for 3 weeks |
| Lenitive cream | Active comparator | Device: lenitive creamPatients will applicate Lenitive cream 3 times per day for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both sexes;
- Aged over 18 years;
- Willing and able to return to the study site for post-procedural assessments;
- Agree to take precautions to prevent pregnancy (applicable only to non-menopausal female subjects), including abstinence, intrauterine device (IUD), progestin implants, combined estrogen-progestin contraceptives, or condom use;
- Agree to sign the informed consent form.
Key exclusion criteria (12 listed)
- Patients with grade III severity according to of HFS severity (Hand-Foot Syndrome- NCI-CTCAE v.0 Severity Grading.
- ECOG Performance Status Scale = 3 or 4
- Pregnancy (applicable only to non-menopausal female subjects);
- Breastfeeding (applicable only to non-menopausal female subjects);
- Non-menopausal female subjects not using the specified contraceptive measures to prevent pregnancy during the study;
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 |
|---|---|---|
| Uracil 0,5% plastersPatients will applicate to hands and feet the plaster twice per day for 3 weeks to reduce the HFS grade. | Device | Experimental device |
| lenitive creamPatients will applicate the cream 3 times per day for 3 weeks to compare the change of HFS severity | Device | Lenitive cream |
Primary outcome
Adverse events number
Time frame: 3 weeks, from the start to the end of the trial
Number of Adverse events during the treatment
Complete healing of the lesions according to HFS severity scale
Time frame: 3 weeks, from beginning to end of the trial
Complete healing of the hands or feet lesions without chemotherapy dosage reduction, using HFS severity scales to assess the absence of symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Yes. The trial results will be published on scientific paper
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uracil 0,5% plasters and lenitive cream in people with HFS, run by Wooshin Labottach Co., Ltd. at 1 site in Italy.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 30 Mar 2026. 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 Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Bollina, Prof. (+39 3356070900, rbollina@asst-rhodense.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events number (time frame: 3 weeks, from the start to the end of the trial). The study lists 2 primary outcomes in all. 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 30 Mar 2026.