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Bariederm Cream in Chronic Contact Dermatitis

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ClinicalTrials.gov Identifier: NCT02026700
Recruitment Status : Unknown
Verified January 2014 by rliranoHMO, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 3, 2014
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Contact Dermatitis Device: bariederm cream

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bariederm Cream in Chronic Contact Dermatitis
Study Start Date : February 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015
Arms and Interventions

Arm Intervention/treatment
Experimental: bariederm, barrier cream
one arm study: use of bariederm cream on hands twice daily for 21 days
Device: bariederm cream
patients are asked to apply twice a day a barrier cream on their hands for 3 weeks only
Other Name: use of bariederm cream on hands twice daily for 21 days


Outcome Measures

Primary Outcome Measures :
  1. self evaluation of effectiveness and tolerance in a 1-10 scale [ Time Frame: 21 days ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with dermatitis of the hands

Exclusion Criteria:

  • pregnant ladies,
  • known allergy to ingredients -
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026700


Contacts
Contact: liran horev, md 00972508573992 rlirano@hadassah.org.il

Locations
Israel
: Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Liran Horev Yakir, MD Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel
More Information

Responsible Party: rliranoHMO, DR, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02026700     History of Changes
Other Study ID Numbers: bariederm-HMO-CTIL
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous