NCT00771121

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

First QC Date

October 10, 2008

Last Update Submit

October 10, 2008

Conditions

Study Arms (2)

new emulsion

ACTIVE COMPARATOR
Drug: urea/lactic acid

new emulsion placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

new emulsion type

new emulsion

only emulsion base

new emulsion placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sophiahemmet

Stockholm, Stockholm County, 114 86, Sweden

RECRUITING

Sophiahemmet

Stockholm, Stockholm County, 114 86, Sweden

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 10, 2008

First Posted

October 13, 2008

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations