Bariederm Cream in Chronic Contact Dermatitis

Hadassah Medical Center

Status: Unknown

Conditions: Contact Dermatitis

Treatments: Device: bariederm cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02026700

bariederm-HMO-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with dermatitis of the hands

Exclusion criteria

• pregnant ladies,
• known allergy to ingredients -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

bariederm, barrier cream

Experimental group

Description:

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

Treatment:

Device: bariederm cream