Clinical trial NCT02840955: The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis
Official title: The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Staphylococcus aureus
Microbiome
Staphefekt
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Micreos
name: TNO
name: Regional Public Health Laboratory Kennemerland
First posted: 2016-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Difference in mean grams/week topical corticosteroid use between verum and placebo group
timeFrame: baseline, 12 and 20 weeks
measure: 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
timeFrame: baseline, 2, 12 and 20 weeks
measure: Change in Eczema Area and Severity Index (EASI) from baseline to week 2, 6, 12 and 20
timeFrame: baseline, 2, 6, 12 and 20 weeks
measure: Change in Patient Orientated Eczema Measurement (POEM) from baseline to week 2, 6, 12 and 20
timeFrame: baseline, 2, 6, 12 and 20 weeks
measure: Change in Investigator Global Assessment (IGA) scale from baseline to week 2, 6 and 12 and week 20
timeFrame: baseline, 2, 6, 12 and 20 weeks
measure: Change in Pruritus Numerical Rating Scale (Pruritus NRS) from baseline to week 2, 6, 12 and week 20
timeFrame: baseline, 2, 6, 12 and 20 weeks
measure: 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.
timeFrame: baseline, 12 and 20 weeks
measure: Number of flares through week 12
timeFrame: baseline, 12 weeks
measure: Change in Skindex-29 score from baseline to week 12 and week 20
timeFrame: baseline, 12 and 20 weeks
measure: 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
timeFrame: baseline, 1 day
measure: 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)
timeFrame: baseline (visit 1 or 2a), 2 and 12 weeks
measure: Change in relative abundance of bacteria: determined by 16 Svedberg units ribosomal ribonucleic acid (16s rRNA) sequencing
timeFrame: baseline, 2, 12 and 20 weeks
measure: Incidence of (serious) adverse device events from baseline through the end of the study, evaluated by medical check-ups, including vital signs
timeFrame: baseline, 20 weeks
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
Study officials:
References:
citation: 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.