NCT02026700

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

December 22, 2013

Last Update Submit

January 2, 2014

Conditions

Contact Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

bariederm, barrier cream

EXPERIMENTAL

one arm study: use of bariederm cream on hands twice daily for 21 days

Device: bariederm cream

Interventions

bariederm creamDEVICE

patients are asked to apply twice a day a barrier cream on their hands for 3 weeks only

Also known as: use of bariederm cream on hands twice daily for 21 days
bariederm, barrier cream

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with dermatitis of the hands

You may not qualify if:

  • pregnant ladies,
  • known allergy to ingredients -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

: Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Liran Horev Yakir, MD

    Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

liran horev, md

CONTACT

00972508573992rlirano@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

December 22, 2013

First Posted

January 3, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

IL(1)