Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)

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:

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 Overview

• Status: Not yet recruiting
• Conditions: HFS
• Intervention / Treatment: Device: Uracil 0,5% plasters; Device: lenitive cream

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Bollina, Prof.; Phone Number: +39 3356070900; Email: rbollina@asst-rhodense.it

Study Locations

• Italy
  • MI
    • Rho, MI, Italy, 20017
      • Presidio Ospedaliero Di Rho - Asst Rhodense- Oncology Department
      • Contact: Roberto Bollina, Prof; Phone Number: +393356070900; Email: rbollina@asst-rhodense.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• 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.

Exclusion criteria

• 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);
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental device; Patients will applicate Uracil plasters twice per day for 3 weeks	Device: Uracil 0,5% plasters; Patients will applicate to hands and feet the plaster twice per day for 3 weeks to reduce the HFS grade.
Active Comparator: Lenitive cream; Patients will applicate Lenitive cream 3 times per day for 3 weeks	Device: lenitive cream; Patients will applicate the cream 3 times per day for 3 weeks to compare the change of HFS severity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events number	Number of Adverse events during the treatment	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.	3 weeks, from beginning to end of the trial

Collaborators and Investigators

• Sponsor: Wooshin Labottach Co., Ltd.
• Collaborators: Nextrasearch S.r.l.s.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HFS; Uracil; uracil plaster; HFS in oncologic patients
• Other Study ID Numbers: 2025/AFCV/WOOSHIN/UPT/ONR/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial results will be published on scientific paper
• IPD Sharing Time Frame: as soon as available, w/o time limits.
• IPD Sharing Access Criteria: potentially all the medical class
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No