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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02026700
Other study ID # bariederm-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 22, 2013
Last updated January 2, 2014
Start date February 2014
Est. completion date March 2015

Study information

Verified date January 2014
Source Hadassah Medical Organization
Contact liran horev, md
Phone 00972508573992
Email rlirano@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- patients with dermatitis of the hands

Exclusion Criteria:

- pregnant ladies,

- known allergy to ingredients -

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel : Hadassah Medical Organization, Jerusalem, Israel Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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