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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840955
• Other study ID #: 2016-233
• Status: Completed
• Phase: N/A
• First received: July 11, 2016
• Last updated: February 22, 2018
• Start date: June 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Staphefekt SA.100

Other:
• Placebo

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Centre	Rotterdam

Sponsors (4)

Lead Sponsor	Collaborator
Erasmus Medical Center	Micreos, Regional Public Health Laboratory Kennemerland, TNO

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks		baseline, 12 weeks
Secondary	Difference in mean grams/week topical corticosteroid use between verum and placebo group		baseline, 12 and 20 weeks
Secondary	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
Secondary	Change in Eczema Area and Severity Index (EASI) from baseline to week 2, 6, 12 and 20		baseline, 2, 6, 12 and 20 weeks
Secondary	Change in Patient Orientated Eczema Measurement (POEM) from baseline to week 2, 6, 12 and 20		baseline, 2, 6, 12 and 20 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of flares through week 12		baseline, 12 weeks
Secondary	Change in Skindex-29 score from baseline to week 12 and week 20		baseline, 12 and 20 weeks
Secondary	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
Secondary	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
Secondary	Change in relative abundance of bacteria: determined by 16 Svedberg units ribosomal ribonucleic acid (16s rRNA) sequencing		baseline, 2, 12 and 20 weeks
Secondary	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