Efficacy, Local Tolerance and Patient Acceptability of a... | NCT01084720

Studies
Efficacy, Local Tolerance and Patient Acceptability of a Moisturizing Emollient in Patients With Uremic Xerosis

NCT01084720

Sponsor

Orfagen

Status

Completed

Last Update Posted

Mar 10, 2010Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Uremic Xerosis

Interventions

V0034 CR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Not provided

Completion Date

Dec 2003Actual

First Submitted Date

Mar 9, 2010

First Submission Date that Met QC Criteria

Mar 9, 2010

First Posted Date

Mar 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2010

Last Update Posted Date

Mar 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Name	Type	Description	Arm Group Labels	Other Names
V0034 CR	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of uremic xerosis on the lower legs on day 7	Severity of uremic xerosis on the lower legs on day 7 by the investigator, using a defined 5-point severity scale. A therapeutic response was defined as a decrease of at least 2 grades of the xerosis after 7 days (end of phase I).	7 days

Secondary Outcomes

Measure	Description	Time Frame
Local tolerance of the test product and its vehicle and overall agreement (efficacy, tolerance easiness of use) of the patients for the test product.		56 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes, of at least 10 years of age
Patients undergoing either hemodialysis or peritoneal dialysis due to chronic renal failure
Patients whose xerosis is related to their renal insufficiency status
Patients suffering from moderate to severe xerosis, i.e. with a severity score of at least 2, on two symmetric areas of the lower legs (Phase I test areas)
Patients who have not experienced phototherapy within 8 weeks prior to study entry
Patients with no antipruritic treatment, or with stable antipruritic treatments (e.g. antihistamines, cholestyramine, opioid inhibitors, charcoal) at least 4 weeks before study entry
Written informed consent (Appendix II) from the patients or parents

Exclusion Criteria:

Patients under 10 years of age
Patients undergoing renal dialysis for another reason than MRD
Patients whose xerosis or pruritus is due to another reason than their MRD status
Patients suffering from mild xerosis (score £ 1) on the lower legs
Patients with xerosis of non comparable severity between the lower legs
Patients with a known history of allergy to one of the ingredients contained in the test product
Patient with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
Patients treated with any other emollient/moisturizing topical preparation within the 7 days prior to study entry
Patients with phototherapy within 8 weeks prior to study entry
Patients who started an antipruritic treatment other than phototherapy, or who experienced unstable dosage schedule of antipruritic treatments (e.g. antihistamines, cholestyramin, opiod inhibitors, charcoal) within 4 weeks prior to study entry
Patients who participated in a study within the 3 months prior to study entry
Patients who are not able or willing to follow the study instructions
Patients or parents who refuse to give written informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided