Bariederm Cream in Chronic Contact Dermatitis

NCT ID: NCT02026700

Last Updated: 2014-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Contact Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bariederm, barrier cream

one arm study: use of bariederm cream on hands twice daily for 21 days

Group Type EXPERIMENTAL

bariederm cream

Intervention Type DEVICE

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

Interventions

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bariederm cream

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

Intervention Type DEVICE

Other Intervention Names

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use of bariederm cream on hands twice daily for 21 days

Eligibility Criteria

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Inclusion Criteria

* patients with dermatitis of the hands

Exclusion Criteria

* pregnant ladies,
* known allergy to ingredients -
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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rliranoHMO

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liran Horev Yakir, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel

Locations

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: Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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liran horev, md

Role: CONTACT

00972508573992

Facility Contacts

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Hadas Lemberg, PhD

Role: primary

00 972 2 6777572

Other Identifiers

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bariederm-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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