Bariederm Cream in Chronic Contact Dermatitis
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bariederm Cream in Chronic Contact Dermatitis|
- self evaluation of effectiveness and tolerance in a 1-10 scale [ Time Frame: 21 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02026700
|Contact: liran horev, firstname.lastname@example.org|
|: Hadassah Medical Organization, Jerusalem, Israel||Not yet recruiting|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator:||Liran Horev Yakir, MD||Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel|