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The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction

NCT03212625 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2019-08-22

No results posted yet for this study

Summary

Many investigators have studied for prevention and care of Hand-Foot Skin Reaction(HFSR), and urea cream is typical representative. Recent study was performed prevention effect of urea cream for Hand-Foot Skin Reaction(HFSR) on 871 Chinese. But the study did not designed as placebo-control group and it had big defect in double-blinded.

Therefore, it needs complementary study as double-blinded placebo-controlled trial and effect of urea cream on Korean patient group.

Conditions

Interventions

DRUG

Urea Cream 20%

Sorafenib 400mg (twice daily), Spread urea cream (urea 20%)

DRUG

Placebos

Sorafenib 400mg (twice daily), Spread placebo cream (urea 0%)

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    collaborator INDUSTRY

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Ji Hoon Kim, MD · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-28
Primary Completion
2018-09-20
Completion
2018-09-20

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT03212625 on ClinicalTrials.gov