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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Placebo; Device: Staphefekt SA.100

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Staphefekt SA.100; Staphefekt SA.100 cream, twice daily on (lesional) skin during 12 weeks	Device: Staphefekt SA.100; Other Names: Gladskin
Placebo Comparator: Placebo; Placebo (Gladskin cream without the Staphefekt protein), twice daily on (lesional) skin during 12 weeks	Other: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in mean grams/week topical corticosteroid use between verum and placebo group	baseline, 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
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 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
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 Skindex-29 score from baseline to week 12 and week 20	baseline, 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
Change in relative abundance of bacteria: determined by 16 Svedberg units ribosomal ribonucleic acid (16s rRNA) sequencing	baseline, 2, 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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: TNO; Micreos; Regional Public Health Laboratory Kennemerland

Publications and helpful links

General Publications

• Totte J, de Wit J, Pardo L, Schuren F, van Doorn M, Pasmans S. Targeted anti-staphylococcal therapy with endolysins in atopic dermatitis and the effect on steroid use, disease severity and the microbiome: study protocol for a randomized controlled trial (MAAS trial). Trials. 2017 Aug 31;18(1):404. doi: 10.1186/s13063-017-2118-x.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Microbiome; Staphylococcus aureus; Atopic dermatitis; Staphefekt
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 2016-233