Bariederm Cream in Chronic Contact Dermatitis | NCT02026700

Studies
Bariederm Cream in Chronic Contact Dermatitis

NCT02026700

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jan 3, 2014Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Contact Dermatitis

Interventions

bariederm cream

Countries

Israel

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Dec 22, 2013

First Submission Date that Met QC Criteria

Jan 2, 2014

First Posted Date

Jan 3, 2014Estimated

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

Jan 2, 2014

Last Update Posted Date

Jan 3, 2014Estimated

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

Description Module

Brief Summary

We intend to evaluate the efficiency and tolerability of a barrier cream (bariederm) in protecting hands of individuals with hand dermatitis, either due to allergy or irritation. We believe that the use of the cream would benefit with the skin.

Detailed Description

The aim of the study is the evaluation of the effectiveness, tolerance and cosmetic acceptability of Bariéderm cream among patients presenting with chronic allergic or irritant contact dermatitis of the hands. We shall enrol adults presenting with CONTACT DERMATITIS EXCLUDING FLARE-UPS of the hands: whether allergic or irritant, able to understand the protocol and agrees to sign the information and informed consent form. Bariéderm cream will be applied minimum twice daily over 21 days. Response will be evaluated by self and physician filled questionnaires. effectiveness, tolerance and cosmetic acceptability will be evaluated by a scale of 1-10, 1 meaning "not at all" and 10 meaning "very much". Statistics will be performed by SPSS software with suitable statistical tests. In case of an adverse event caused by the product, patch-test with ingredients of Bariéderm cream will be performed.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bariederm, barrier cream	Experimental	one arm study: use of bariederm cream on hands twice daily for 21 days	Device: bariederm cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bariederm cream	Device	patients are asked to apply twice a day a barrier cream on their hands for 3 weeks only	bariederm, barrier cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
self evaluation of effectiveness and tolerance in a 1-10 scale	effectiveness tolerance and acceptability in adults with hand dermatitis, evaluated by a self reported and a physician reported questionaires, using a 1-10 scale for evaluation.	21 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with dermatitis of the hands

Exclusion Criteria:

pregnant ladies,
known allergy to ingredients -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
liran horev, md	Contact	00972508573992		rlirano@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Liran Horev Yakir, MD	Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
: Hadassah Medical Organization, Jerusalem, Israel		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D003877	Dermatitis, Contact

Ancestor Terms

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous

Browse Leaves

Not provided

Browse Branches

Not provided