CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 288 enrolled
Drug / intervention
Urea Cream 20% +1 moredrug
Likely dose
Urea Cream 20% 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03212625
NCT03212625Phase 4Completed
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The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction in Patients With Korean Hepatocellular Carcinoma Patients: Multicenter, Prospective Randomized Double-Blind Controlled Study

Korea University Guro Hospital·interventional·Posted Jul 11, 2017·Updated Aug 22, 2019

In Brief

A Phase 4 clinical trial evaluating Urea Cream 20% and Placebos for Hepatocellular Carcinoma. Completed, enrolled 288 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesSouth Korea
CollaboratorsHanmi Pharmaceutical Company Limited

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 11, 2017
Enrollment StartJan 28, 2016
Primary CompletionSep 20, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.0 years ago

Interventions

Urea Cream 20%drug

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

Placebosdrug

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