Trial · NCT03212625
The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction
NCT03212625, Phase 4, Completed, Korea University Guro Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction. Trials, record NCT03212625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03212625
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction
- NCT number
- NCT03212625
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 288 participants, actual
- Lead sponsor
- Korea University Guro Hospital
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Urea Cream 20%, Placebos
- First posted
- 2017-07-11
- Last updated
- 2019-08-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative incidence of Hand-Foot Skin Reaction(HFSR) on each group | 12 weeks treatment | Comparison of cumulative incidence of HFSR between placebo group and urea cream group |
| Secondary | Cumulative incidence of severe HFSR on each group | 12 weeks treatment | Comparison of cumulative incidence of severe HFSR (grade 2 or grade 3) between placebo group and urea cream group |
| Secondary | Incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group | 12 weeks treatment | Comparison of incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group |
| Secondary | Assessment of Quality Of Life (QOL) | 12 weeks treatment | Assessment of QOL related to HFSR using The Hand-Foot Skin Reaction and Quality of Life Questionnaire (HF-QoL) scoring system. HF-QOL instrument comprises a 20-item symptom scale and an 18-item daily activity scale. Each item was scored from 0 (not at all) to 4 (always or extremely). Therefore, the range of score for HF-QoL was from 0 to 152 points. (Ref. Anderson et al. The Oncoligist 2015;20:831-838) |
| Secondary | Overall survival | 12 weeks treatment | Overall survival of patients |
| Secondary | Tumor response | 12 weeks treatment | Tumor response using mRECIST criteria |
| Secondary | Other side effect | 12 weeks treatment | The occurrence rate of other side effect excluding HFSR |
| Secondary | Incidence of HFSR on 2, 4, 8, and 12 weeks on each group | 2, 4, 8, and 12 weeks | Comparison of incidence of HFSR on 2, 4, 8, and 12 weeks between placebo group and urea cream group |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03212625
GET https://conductscience.org/api/trials/v1/NCT03212625/registered