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Effect of Moisturizing Creams on Skin Barrier Function

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by ACO Hud Nordic AB.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771121
First Posted: October 13, 2008
Last Update Posted: October 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ACO Hud Nordic AB
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00771121     History of Changes
Other Study ID Numbers: ACO2008-CT-01
First Submitted: October 10, 2008
First Posted: October 13, 2008
Last Update Posted: October 13, 2008
Last Verified: October 2008

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