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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Staphefekt SA.100

Staphefekt SA.100 cream, twice daily on (lesional) skin during 12 weeks

Group Type ACTIVE_COMPARATOR

Staphefekt SA.100

Intervention Type DEVICE

Placebo

Placebo (Gladskin cream without the Staphefekt protein), twice daily on (lesional) skin during 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Staphefekt SA.100

Intervention Type DEVICE

Placebo

Intervention Type OTHER

Other Intervention Names

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Gladskin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No