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

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ClinicalTrials.gov Identifier: NCT02840955
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : February 23, 2018
Sponsor:
Collaborators:
Micreos
TNO
Regional Public Health Laboratory Kennemerland
Information provided by (Responsible Party):
Suzanne G.M.A. Pasmans, Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE July 11, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date February 23, 2018
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks [ Time Frame: baseline, 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02840955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Difference in mean grams/week topical corticosteroid use between verum and placebo group [ Time Frame: 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 [ Time Frame: baseline, 2, 12 and 20 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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. [ Time Frame: baseline, 12 and 20 weeks ]
  • Number of flares through week 12 [ Time Frame: baseline, 12 weeks ]
  • Change in Skindex-29 score from baseline to week 12 and week 20 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, 20 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2016)
  • Difference in mean grams/week topical corticosteroid use between verum and placebo group [ Time Frame: 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 [ Time Frame: baseline, 2, 12 and 20 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in Pruritis Numerical Rating Scale (Pruritis NRS) from baseline to week 2, 6, 12 and week 20 [ Time Frame: 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. [ Time Frame: baseline, 12 and 20 weeks ]
  • Number of flares through week 12 [ Time Frame: baseline, 12 weeks ]
  • Change in Skindex-29 score from baseline to week 12 and week 20 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, 20 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis
Official Title  ICMJE The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Device: Staphefekt SA.100
    Other Name: Gladskin
  • Other: Placebo
Study Arms  ICMJE
  • Active Comparator: Staphefekt SA.100
    Staphefekt SA.100 cream, twice daily on (lesional) skin during 12 weeks
    Intervention: Device: Staphefekt SA.100
  • Placebo Comparator: Placebo
    Placebo (Gladskin cream without the Staphefekt protein), twice daily on (lesional) skin during 12 weeks
    Intervention: Other: Placebo
Publications * Totté 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2018
Actual Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840955
Other Study ID Numbers  ICMJE 2016-233
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suzanne G.M.A. Pasmans, Erasmus Medical Center
Study Sponsor  ICMJE Erasmus Medical Center
Collaborators  ICMJE
  • Micreos
  • TNO
  • Regional Public Health Laboratory Kennemerland
Investigators  ICMJE Not Provided
PRS Account Erasmus Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP