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NCT00771121 Clinical Trial

Effect of Moisturizing Creams on Skin Barrier Function

Atopic Eczema Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00771121
Other study ID # ACO2008-CT-01
Secondary ID
Status Recruiting
Phase Phase 4
First received October 10, 2008
Last updated October 10, 2008

Study information
Verified date October 2008
Source ACO Hud Nordic AB
Contact Lena Holm, Dr
Phone +46 (0)706-382722
Email lena.holm.ab@telia.com
Is FDA regulated No
Health authority Sweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• urea/lactic acid
new emulsion type
• Placebo
only emulsion base

Locations
Country Name City State
Sweden Sophiahemmet Stockholm
Sweden Sophiahemmet Stockholm

Sponsors (1)
Lead Sponsor Collaborator
ACO Hud Nordic AB

Country where clinical trial is conducted

Sweden, 

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