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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38880

Enrollment

170

Registered

2013-03-22

Start date

2013-03-26

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact dermatitis / contact eczema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results