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

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Placebo; Device: Staphefekt SA.100

• Registration Number: NCT02840955
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-21
• Status Verified: 2018-02
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (Gladskin cream without the Staphefekt protein), twice daily on (lesional) skin during 12 weeks
Staphefekt SA.100	Staphefekt SA.100	Staphefekt SA.100 cream, twice daily on (lesional) skin during 12 weeks

Primary Outcome Measures

Name	Time	Method
Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks	baseline, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Patient Orientated Eczema Measurement (POEM) from baseline to week 2, 6, 12 and 20	baseline, 2, 6, 12 and 20 weeks
Change in Investigator Global Assessment (IGA) scale from baseline to week 2, 6 and 12 and week 20	baseline, 2, 6, 12 and 20 weeks
Incidence of (serious) adverse device events from baseline through the end of the study, evaluated by medical check-ups, including vital signs	baseline, 20 weeks
Change in Skindex-29 score from baseline to week 12 and week 20	baseline, 12 and 20 weeks
Difference in mean grams/week topical corticosteroid use between verum and placebo group	baseline, 12 and 20 weeks
Change in Eczema Area and Severity Index (EASI) from baseline to week 2, 6, 12 and 20	baseline, 2, 6, 12 and 20 weeks
Change in Pruritus Numerical Rating Scale (Pruritus NRS) from baseline to week 2, 6, 12 and week 20	baseline, 2, 6, 12 and 20 weeks
Mean time to flare from baseline through week 12 and from week 12 through week 20. Flare is defined is an exacerbation that requires the need of any stronger topical therapy, an increase in dosage of the topical therapy or the need of a systemic therapy.	baseline, 12 and 20 weeks
Number of flares through week 12	baseline, 12 weeks
Change in relative abundance of bacteria: determined by 16 Svedberg units ribosomal ribonucleic acid (16s rRNA) sequencing	baseline, 2, 12 and 20 weeks
Proportion of patients with AD who indicate to have used less corticosteroids at week 2 and 12, as compared to baseline and at week 20 as compared to the 12 week treatment period	baseline, 2, 12 and 20 weeks
Proportion of patients with a reduction of S. aureus from baseline to measurement 1 (0,5 hour after baseline) as determined by semi quantitative culture	baseline, 1 day
Proportion of patient with a > 1 log reduction of S. aureus from the lowest measurement (visit 1 or visit 2a) to week 2 and week 12 as determined by quantitative polymerase chain reaction (qPCR)	baseline (visit 1 or 2a), 2 and 12 weeks

Trial Locations

Locations (1)

Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands