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
About this trial
This is an interventional trial for Atopic Eczema
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.
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
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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