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Effect of Moisturizing Creams on Skin Barrier Function

NCT ID: NCT00771121

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Eczema

Study Groups

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new emulsion

Group Type ACTIVE_COMPARATOR

urea/lactic acid

Intervention Type DRUG

new emulsion type

new emulsion placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

only emulsion base

Interventions

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urea/lactic acid

new emulsion type

Intervention Type DRUG

Placebo

only emulsion base

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ACO Hud Nordic AB

INDUSTRY

Sponsor Role lead

Locations

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Sophiahemmet

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Sophiahemmet

Stockholm, Stockholm County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Lena Holm, Dr

Role: CONTACT

Phone: +46 (0)706-382722

Email: [email protected]

Facility Contacts

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Lena Holm, Dr

Role: primary

Lena Holm, Dr

Role: primary

Other Identifiers

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ACO2008-CT-01

Identifier Type: -

Identifier Source: org_study_id