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Effect of Moisturizing Creams on Skin Barrier Function

Primary Purpose

Atopic Eczema

Status
Unknown status
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
urea/lactic acid
Placebo
Sponsored by
ACO Hud Nordic AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Atopic Eczema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SophiahemmetRecruiting
  • SophiahemmetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

new emulsion

new emulsion placebo

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 10, 2008
Last Updated
October 10, 2008
Sponsor
ACO Hud Nordic AB
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1. Study Identification

Unique Protocol Identification Number
NCT00771121
Brief Title
Effect of Moisturizing Creams on Skin Barrier Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ACO Hud Nordic AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Eczema

7. Study Design

Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
new emulsion
Arm Type
Active Comparator
Arm Title
new emulsion placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
urea/lactic acid
Intervention Description
new emulsion type
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
only emulsion base

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Holm, Dr
Phone
+46 (0)706-382722
Email
lena.holm.ab@telia.com
Facility Information:
Facility Name
Sophiahemmet
City
Stockholm
ZIP/Postal Code
114 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Holm, Dr
Phone
+46 (0)706-382722
Email
lena.holm.ab@telia.com
Facility Name
Sophiahemmet
City
Stockholm
ZIP/Postal Code
114 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Holm, Dr
Phone
0706-382722
Email
lena.holm.ab@telia.com
First Name & Middle Initial & Last Name & Degree
Lena Holm, Dr

12. IPD Sharing Statement

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Effect of Moisturizing Creams on Skin Barrier Function

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