Bariederm Cream in Chronic Contact Dermatitis

Not Applicable

• Conditions: Contact Dermatitis
• Interventions: Device: bariederm cream

• Registration Number: NCT02026700
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study First Submitted: 2013-12-22
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-02
• Last Update Submitted: 2014-01-02
• Study First Posted: 2014-01-03
• Last Update Posted: 2014-01-03
• Study Start: 2014-02
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients with dermatitis of the hands

Exclusion Criteria

• pregnant ladies,
• known allergy to ingredients -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bariederm, barrier cream	bariederm cream	one arm study: use of bariederm cream on hands twice daily for 21 days

Primary Outcome Measures

Name	Time	Method
self evaluation of effectiveness and tolerance in a 1-10 scale	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.

Trial Locations

Locations (1)

: Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel