Determination of Safety and Consumers' Satisfaction of Mo... | NCT01167465

Studies
Determination of Safety and Consumers' Satisfaction of Moussik Versus Desitin Creamy Ointment in Diaper Rash Prophylaxis

NCT01167465

Sponsor

Trima, Israel Pharmaceutical Products

Status

Withdrawn

Last Update Posted

Dec 17, 2014Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Diaper Rash

Interventions

Moussik Diaper Rash Mousse
Desitin Creamy Ointment

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

Dec 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 20, 2010

First Submission Date that Met QC Criteria

Jul 21, 2010

First Posted Date

Jul 22, 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

Dec 16, 2014

Last Update Posted Date

Dec 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

The purpose of this clinical observation is to evaluate the safety and consumers' satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.

Detailed Description

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moussik Diaper Rash Mousse	Other	To be used as instructed
Desitin Creamy Ointment	Other	To be used as instructed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Six point erythema skin grade	0 - Normal skin + - Questionable erthema not covering entire area - Definite erythema - Erythema and induration - Vesiculation - Blister reaction	After two weeks

Secondary Outcomes

Measure	Description	Time Frame
Visual analogue scale (VAS) from 0 to 10		After two weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers

Exclusion Criteria:

Children with symptoms of systemic disease or skin lesions.
Children diagnosed as having diaper dermatitis at baseline
Known hypersensitivity to any of the components of the trial preparations.
Children suffering from atopic diseases.
Children who have participated during the last month in another clinical trial.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kobi Shiff, MD		Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D003963	Diaper Rash
D004890	Erythema

Ancestor Terms

ID	Term
D017453	Dermatitis, Irritant
D003877	Dermatitis, Contact
D003872	Dermatitis
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided