Efficacy of a skin barrier repair cream (Dermalex Eczema) in atopic dermatitis patients

Completed

Conditions: atopic Dermatitis
Atopic eczema
10014982

Registration Number: NL-OMON41112

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Clinically diagnosed atopic dermatitis;- Mild to moderate atopic dermatitis, according to total SCORAD score (score <25) ;- Age between 18 and 70 years;- Written informed consent ;- At least two symmetrical (i.e. left and right side of the body) skin sites with comparable AD severity (Measured in SCORAD-score)

Exclusion Criteria

Extensive UV exposure in the last 14 days before study and/or expected during the study. ;- Other skin disease other than AD.;- Use of antibiotics prior to (4 weeks) the study and/or expected use during the study.;- Use of systemic suppressing drugs (e.g. prednisone, methothrexate) prior to (4 weeks) the study and/or expected use during the study;-Severe disorders within the last 6 months before study (e.g. cancer, acute cardiac or circularity disorders, HIV, infectious hepatitis);- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The duration in days of used ointments until AD symptoms have improved, defined<br /><br>as a decrease in SCORAD-score of 5 points</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The amount of used cream/ointments (per day and total)<br /><br>- Change in cytokine levels, lipid profile, Trans epidermal water loss,<br /><br>erythema and PH after the different treatments.<br /><br>- presence of mutations on the Fillagrin-gene</p><br>