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Effect of Moisturizing Creams on Skin Barrier Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by ACO Hud Nordic AB.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
ACO Hud Nordic AB
ClinicalTrials.gov Identifier:
NCT00771121
First received: October 10, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo.


Condition Intervention Phase
Atopic Eczema
 Drug: urea/lactic acid
Drug: Placebo
 Phase 4

Study Type: Interventional

Resource links provided by NLM:

MedlinePlus related topics: Eczema
U.S. FDA Resources

Further study details as provided by ACO Hud Nordic AB:

Arms Assigned Interventions
Active Comparator: new emulsion Drug: urea/lactic acid
new emulsion type
Placebo Comparator: new emulsion placebo Drug: Placebo
only emulsion base

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dry skin barrier disorders such as atopic dermatitis or Malassezia eradicated head and neck dermatitis.
  • Rough or clinically normal skin on the volar aspect of the forearm.
  • Either gender
  • Age between 18 and 65 years
  • Written Informed Consent

Exclusion Criteria:

  • Possible allergy to ingredients in the study medications.
  • Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy.
  • Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse).
  • Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results.
  • Pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771121

Contacts
Contact: Lena Holm, Dr +46 (0)706-382722 lena.holm.ab@telia.com

Locations
Sweden
Sophiahemmet Recruiting
Stockholm, Sweden, 114 86
Contact: Lena Holm, Dr     +46 (0)706-382722     lena.holm.ab@telia.com    
Sophiahemmet Recruiting
Stockholm, Sweden, 114 86
Contact: Lena Holm, Dr     0706-382722     lena.holm.ab@telia.com    
Principal Investigator: Lena Holm, Dr            
Sponsors and Collaborators
ACO Hud Nordic AB
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00771121     History of Changes
Other Study ID Numbers: ACO2008-CT-01
Study First Received: October 10, 2008
Last Updated: October 10, 2008
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Dermatitis, Atopic
Eczema
Skin Diseases, Genetic
Genetic Diseases, Inborn
Dermatitis
 Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013