MedTrace Logo

Efficacy and Safety of Moisturising Cream With or Without Vitamin E and Urea Cream in Palmar-plantar Erythrodysesthesia

NCT05939726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2026-01-14

No results posted yet for this study

Summary

This is a single-centre, phase II, three-arm, randomised controlled trial to evaluate the efficacy and safety of a cosmetic moisturising cream containing palm-oil-derived vitamin E concentrate or a similar moisturising cream without the vitamin E concentrate in addition to urea-based cream, or urea-based cream alone (1:1:1) in patients who are receiving capecitabine-based cancer therapy and develop capecitabine-associated PPE of NCI-CTCAE grade 1.

Conditions

  • Palmar-Plantar Erythrodysesthesia
  • Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy

Interventions

OTHER

Moisturising cream with vitamin E concentrate

The vitamin E moisturising cream contains 3% w/w of palm-oil-derived vitamin E concentrate, consisting of the following isomers: alpha-tocopherol, alpha-tocotrienol, beta-tocotrienol, gamma-tocotrienol, and delta-tocotrienol. This formula provides a total of 1.2g tocotrienols per 100g product.

OTHER

Moisturising cream without vitamin E concentrate

This moisturising cream is a similar moisturising cream but without the addition of the vitamin E concentrate

OTHER

Urea cream

Urea cream (10%w/w) is used as the standard of care for PPE.

Sponsors & Collaborators

  • Avantsar Sdn. Bhd.

    collaborator UNKNOWN

  • Universiti Sains Malaysia

    collaborator OTHER

  • Sarawak General Hospital

    lead OTHER

Principal Investigators

  • Pei Jye Voon, M.D · Sarawak General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2025-05-22
Completion
2025-06-20

Countries

  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939726 on ClinicalTrials.gov