CompletedPhase 4

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

South Korea288 participantsStarted 2016-01-28

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. Suitable on hepatocellular carcinoma pathologically
✓. Hepatic nodule size over 1 cm on high-risk patients(hepatitis B virus positive, hepatitis C virus positive and liver cirrhosis) that identified by ultrasonography : In the case of suitable on hepatocellular carcinoma on over in one or two more dynamic contrast enhanced CT, dynamic contrast enhanced MRI, or MRI with Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid(Gd-EOB-DTPA)
✓. Hepatic nodule size under 1 cm on high-risk patients that identified by ultrasonography : serum Alpha-fetoprotein(AFP) elevated over normal range constantly when hepatitis activity was restrained, and the case of suitable on hepatocellular carcinoma on over in two more the above image diagnoses

What they're measuring

Cumulative incidence of Hand-Foot Skin Reaction(HFSR) on each group

Timeframe: 12 weeks treatment

Trial details

NCT IDNCT03212625

SponsorKorea University Guro Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-20

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