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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Staphefekt SA.100

Placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Staphylococcus aureus, Microbiome, Staphefekt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Erasmus Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Staphefekt SA.100

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks

Secondary Outcome Measures

Difference in mean grams/week topical corticosteroid use between verum and placebo group

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

Change in Eczema Area and Severity Index (EASI) from baseline to week 2, 6, 12 and 20

Change in Patient Orientated Eczema Measurement (POEM) from baseline to week 2, 6, 12 and 20

Change in Investigator Global Assessment (IGA) scale from baseline to week 2, 6 and 12 and week 20

Change in Pruritus Numerical Rating Scale (Pruritus NRS) from baseline to week 2, 6, 12 and week 20

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.

Number of flares through week 12

Change in Skindex-29 score from baseline to week 12 and week 20

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

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)

Change in relative abundance of bacteria: determined by 16 Svedberg units ribosomal ribonucleic acid (16s rRNA) sequencing

Incidence of (serious) adverse device events from baseline through the end of the study, evaluated by medical check-ups, including vital signs

Full Information

NCT ID

NCT02840955

First Posted

July 11, 2016

Last Updated

February 22, 2018

Sponsor

Erasmus Medical Center

Collaborators

Micreos, TNO, Regional Public Health Laboratory Kennemerland

1. Study Identification

Unique Protocol Identification Number

NCT02840955

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Erasmus Medical Center

Collaborators

Micreos, TNO, Regional Public Health Laboratory Kennemerland

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Atopic dermatitis, Staphylococcus aureus, Microbiome, Staphefekt

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Staphefekt SA.100

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Staphefekt SA.100

Other Intervention Name(s)

Gladskin

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks

Time Frame

baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Difference in mean grams/week topical corticosteroid use between verum and placebo group

Time Frame

baseline, 12 and 20 weeks

Title

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

Time Frame

baseline, 2, 12 and 20 weeks

Title

Change in Eczema Area and Severity Index (EASI) from baseline to week 2, 6, 12 and 20

Time Frame

baseline, 2, 6, 12 and 20 weeks

Title

Change in Patient Orientated Eczema Measurement (POEM) from baseline to week 2, 6, 12 and 20

Time Frame

baseline, 2, 6, 12 and 20 weeks

Title

Change in Investigator Global Assessment (IGA) scale from baseline to week 2, 6 and 12 and week 20

Time Frame

baseline, 2, 6, 12 and 20 weeks

Title

Change in Pruritus Numerical Rating Scale (Pruritus NRS) from baseline to week 2, 6, 12 and week 20

Time Frame

baseline, 2, 6, 12 and 20 weeks

Title

Time Frame

baseline, 12 and 20 weeks

Title

Number of flares through week 12

Time Frame

baseline, 12 weeks

Title

Change in Skindex-29 score from baseline to week 12 and week 20

Time Frame

baseline, 12 and 20 weeks

Title

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

Time Frame

baseline, 1 day

Title

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)

Time Frame

baseline (visit 1 or 2a), 2 and 12 weeks

Title

Change in relative abundance of bacteria: determined by 16 Svedberg units ribosomal ribonucleic acid (16s rRNA) sequencing

Time Frame

baseline, 2, 12 and 20 weeks

Title

Incidence of (serious) adverse device events from baseline through the end of the study, evaluated by medical check-ups, including vital signs

Time Frame

baseline, 20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Erasmus Medical Centre

City

Rotterdam

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

28859690

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.

Results Reference

derived

Learn more about this trial

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

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