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

NCT07501442 | Not Yet Recruiting

• 1 other identifier: 2025/AFCV/WOOSHIN/UPT/ONR/09
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Uracil; uracil plaster; HFS; HFS in oncologic patients

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental device

EXPERIMENTAL

Patients will applicate Uracil plasters twice per day for 3 weeks

Device: Uracil 0,5% plasters

Lenitive cream

ACTIVE COMPARATOR

Patients will applicate Lenitive cream 3 times per day for 3 weeks

Device: lenitive cream

Interventions

Uracil 0,5% plasters DEVICE

Patients will applicate to hands and feet the plaster twice per day for 3 weeks to reduce the HFS grade.

Experimental device

lenitive cream DEVICE

Patients will applicate the cream 3 times per day for 3 weeks to compare the change of HFS severity

Lenitive cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wooshin Labottach Co., Ltd.: lead
• Nextrasearch S.r.l.s.: collaborator

Study Sites (1)

Presidio Ospedaliero Di Rho - Asst Rhodense- Oncology Department

Rho, MI, 20017, Italy

Location

Central Study Contacts

Roberto Bollina, Prof.

CONTACT

+39 3356070900; rbollina@asst-rhodense.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric, two arms (experimental device vs. standard lenitive cream), single blind interventional study

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: as soon as available, w/o time limits.
• Access Criteria: potentially all the medical class

Locations

IT (1)