The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis

Erasmus University

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Other: Placebo

Device: Staphefekt SA.100

Study type

Interventional

Funder types

Other

Identifiers

NCT02840955

2016-233

Details and patient eligibility

About

Colonization with Staphylococcus aureus is related to inflammation in atopic dermatitis. Gladskin is a product for topical use containing the proprietary enzyme Staphefekt SA.100, which has the ability to specifically lyse the cell wall of S. aureus. The investigators hypothesize that Staphefekt decreases S. aureus colonization of the skin and consequently decreases symptoms of atopic dermatitis.The goal of this study is to determine the effect of Staphefekt on the use of topical corticosteroids in patients with atopic dermatitis. Secondary goals are to retrieve information about the effect on clinical symptoms, quality of life, growth characteristics of Staphylococcus aureus and the further microbiome.

Full description

This is a multi center intervention study with a placebo controlled, double blind and randomized design. After standardization of corticosteroid treatment (triamcinolone acetonide 0.1% cream), patients will be randomized in a 1:1 fashion to either treatment with Staphefekt SA.100 for 12 weeks or treatment with a placebo for 12 weeks. Topical corticosteroid use will be evaluated 2, 6, 12 and 20 weeks after start of the intervention. Swabs of the skin, nose and throat will be collected at baseline, week 2, 12 and 20.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Atopic dermatitis of moderate and severe severity. Defined by EASI score of 7.1 to 50 performed by the researcher at visit 1
Topical corticosteroid use (of any type)
18 years or older
Able to read patient information and provide informed consent

Exclusion criteria

Use of systemic antibiotics or corticosteroids in the previous 2 months
Use of Methotrexate or oral immunosuppressive agents in the previous 3 months
Use of topical antibiotics in the previous 7 days
Use of light therapy in the previous 3 months
Use of Gladskin in the previous 7 days
Contact allergy to components of the study drug (e.g., propylene glycol and glycerol)
Clinically infected atopic dermatitis
Existence of another skin condition, such as folliculitis or psoriasis that could interfere with the assessment of the eczema severity