Efficacy of a skin protecting cream in skin barrier protection and repair

Completed

Conditions: Contact dermatitis / contact eczema
10014982

Registration Number: NL-OMON38880

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 170

Inclusion Criteria

1) age between 18 and 55 years,
2) Caucasian race of Western Europe origin

Exclusion Criteria

1) dermatitis on mid-volar arms
2) systemic inflammation disease
3) skin disease other than AD
4) use of antihistaminics or inflammation suppressing medicines (e.g. corticosteroids, NSAIDs) or antibiotics one month prior to, and during the investigation.
5) sunbathing or using a tanning bed during 2 months prior to, and during the investigation

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the skin barrier and irritation response the following parameters<br /><br>will be measured:<br /><br><br /><br>1. Transepidermal water loss (TEWL), pH and erythema<br /><br>2. Levels of natural moisturizing factors (NMFs) (including<br /><br>2-pyrrolidone-5-carboxylic acid, histidine and urocanic acid) and cytokines<br /><br>(including IL-1a, IL-1β, Il-1RA, IL-8 and IL-10) in the stratum corneum<br /><br>harvested by using adhesive tape<br /><br>3. Skin morphology as assessed by using confocal laser scan microscopy<br /><br>(Vivascope 1500, MAVIG, Germany)<br /><br>4. Lipids (ceramides and free fatty acids) in the stratum corneum harvested by<br /><br>using adhesive tape</p><br>

Secondary Outcome Measures