Trial record 5 of 19 for:    Open Studies | "Dermatitis, Contact"

Bariederm Cream in Chronic Contact Dermatitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
rliranoHMO, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT02026700
First received: December 22, 2013
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Contact Dermatitis
Device: bariederm cream

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bariederm Cream in Chronic Contact Dermatitis

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with dermatitis of the hands

Exclusion Criteria:

  • pregnant ladies,
  • known allergy to ingredients -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026700

Contacts
Contact: liran horev, md 00972508573992 rlirano@hadassah.org.il

Locations
Israel
: Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Liran Horev Yakir, MD Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel
  More Information

No publications provided

Responsible Party: rliranoHMO, DR, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02026700     History of Changes
Other Study ID Numbers: bariederm-HMO-CTIL
Study First Received: December 22, 2013
Last Updated: January 2, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on August 28, 2014