Trial · NCT01084148

Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

NCT01084148, Phase 3, Completed, Orfagen; results first posted 2014-03-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis. Trials, record NCT01084148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01084148

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
NCT number: NCT01084148
Status: Completed
Phases: Phase 3
Enrollment: 237 participants, actual
Lead sponsor: Orfagen
Conditions: Uremic Xerosis
Interventions: V0034CR01B, V0034CR01B vehicle
First posted: 2010-03-10
Last updated: 2017-12-20
Results first posted: 2014-03-18

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Response of Xerosis	28 days	Treatment response rate of uremic xerosis on 5 test areas (right lower leg, left lower leg, forearm having no arterio-venous shunt, chest, dorsum of the neck), using a defined 5-point severity scale: 0 = smooth skin 1. = patches of fine, powdery scales 2. = diffuse ashy appearance with many fine scales 3. = moderate scaling with beginning cracks 4. = intense scaling, moderate cracks Treatment response was defined as a score of 0 or 1 on all test areas at the end of Period I, and a reduction of at least 2 grades on at least one test area (primary efficacy parameter, Period I).
Secondary	Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	133 days	At the end of treatment (day 133), patients assessed their overall agreement on the local tolerance of the test product, using a 4-point scale, as follows : 1. = very satisfactory 2. = satisfactory 3. = poorly satisfactory 4. = not satisfactory at all

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Response of Xerosis	28 days	One patient in V0034 CR 01B Vehicle arm randomized but not treated	participants	NUMBER
SECONDARY	Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	133 days		participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Treatment Response of Xerosis	V0034CR01B		71	participants
Treatment Response of Xerosis	V0034 CR 01B Vehicle		48	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034CR01B	Very satistactory	68	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034 CR 01B Vehicle	Very satistactory	77	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034CR01B	Satisfactory	26	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034 CR 01B Vehicle	Satisfactory	32	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034CR01B	Poorly satisfactory	5	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034 CR 01B Vehicle	Poorly satisfactory	4	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034CR01B	Not satisfactory at all	6	participants
Local Tolerance of V0034 CR 01B After Long-term Use and Patient's Benefit and Acceptability of V0034 CR 01B	V0034 CR 01B Vehicle	Not satisfactory at all	1	participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	V0034CR01B	118
Overall Study	STARTED	V0034 CR 01B Vehicle	118
Overall Study	Treated Patients	V0034CR01B	118
Overall Study	Treated Patients	V0034 CR 01B Vehicle	117
Overall Study	COMPLETED	V0034CR01B	88
Overall Study	COMPLETED	V0034 CR 01B Vehicle	102
Overall Study	NOT COMPLETED	V0034CR01B	30
Overall Study	NOT COMPLETED	V0034 CR 01B Vehicle	16

Source ClinicalTrials.gov

Adverse events196

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dermatitis allergic	Skin and subcutaneous tissue disorders	V0034CR01B	1	118
other	Dermatitis allergic	Skin and subcutaneous tissue disorders	V0034 CR 01B Vehicle	0	117
other	Abdominal pain	Gastrointestinal disorders	V0034CR01B	0	118
other	Abdominal pain	Gastrointestinal disorders	V0034 CR 01B Vehicle	1	117
other	Anaemia	Blood and lymphatic system disorders	V0034CR01B	1	118
other	Anaemia	Blood and lymphatic system disorders	V0034 CR 01B Vehicle	0	117
other	Angina pectoris	Cardiac disorders	V0034CR01B	1	118
other	Angina pectoris	Cardiac disorders	V0034 CR 01B Vehicle	0	117
other	Ankle fracture	Injury, poisoning and procedural complications	V0034CR01B	1	118
other	Ankle fracture	Injury, poisoning and procedural complications	V0034 CR 01B Vehicle	0	117

1 to 10 of 196Source ClinicalTrials.gov

See all 196 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	V0034CR01B
Total, all-cause mortality	V0034 CR 01B Vehicle
Total, other adverse events	V0034CR01B	40	118
Total, other adverse events	V0034 CR 01B Vehicle	39	117
Total, serious adverse events	V0034CR01B	16	118
Total, serious adverse events	V0034 CR 01B Vehicle	19	117

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39422853	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
V0034CR01B vs V0034 CR 01B Vehicle: Treatment Response of Xerosis	Trial comparisons
V0034CR01B vs V0034 CR 01B Vehicle: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01084148

GET https://conductscience.org/api/trials/v1/NCT01084148/events?page=2

API reference For AI assistants