Back to resultsBariederm Cream in Chronic Contact Dermatitis
Primary Purpose
Contact Dermatitis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
bariederm cream
Sponsored by
About this trial
This is an interventional treatment trial for Contact Dermatitis
Eligibility Criteria
Inclusion Criteria:
- patients with dermatitis of the hands
Exclusion Criteria:
- pregnant ladies,
- known allergy to ingredients -
Sites / Locations
- : Hadassah Medical Organization, Jerusalem, Israel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bariederm, barrier cream
Arm Description
one arm study: use of bariederm cream on hands twice daily for 21 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02026700
First Posted
December 22, 2013
Last Updated
January 2, 2014
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT02026700
Brief Title
Bariederm Cream in Chronic Contact Dermatitis
Official Title
Bariederm Cream in Chronic Contact Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bariederm, barrier cream
Arm Type
Experimental
Arm Description
one arm study: use of bariederm cream on hands twice daily for 21 days
Intervention Type
Device
Intervention Name(s)
bariederm cream
Other Intervention Name(s)
use of bariederm cream on hands twice daily for 21 days
Intervention Description
patients are asked to apply twice a day a barrier cream on their hands for 3 weeks only
Primary Outcome Measure Information:
Title
self evaluation of effectiveness and tolerance in a 1-10 scale
Description
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.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with dermatitis of the hands
Exclusion Criteria:
pregnant ladies,
known allergy to ingredients -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
liran horev, md
Phone
00972508573992
Email
rlirano@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liran Horev Yakir, MD
Organizational Affiliation
Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
: Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
12. IPD Sharing Statement
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Bariederm Cream in Chronic Contact Dermatitis
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