NCT02840955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

July 11, 2016

Last Update Submit

February 22, 2018

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisStaphylococcus aureusMicrobiomeStaphefekt

Outcome Measures

Primary Outcomes (1)

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

    baseline, 12 weeks

Secondary Outcomes (13)

  • 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

  • +8 more secondary outcomes

Study Arms (2)

Staphefekt SA.100

ACTIVE COMPARATOR

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

Device: Staphefekt SA.100

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Staphefekt SA.100DEVICE
Also known as: Gladskin
Staphefekt SA.100
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • years or older
  • Able to read patient information and provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Centre

Rotterdam, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28859690DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicStaphylococcal Infections

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 21, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

NL(1)