Bariederm Cream in Chronic Contact Dermatitis

Contact Dermatitis Clinical Trial

Official title:

Bariederm Cream in Chronic Contact Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02026700
• Other study ID #: bariederm-HMO-CTIL
• 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

• Contact Dermatitis
• Dermatitis
• Dermatitis, Contact
• Eczema

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