Atopic DermatitisNCT02840955
The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis
A study testing Staphefekt SA.100 in people with Atopic Dermatitis, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Staphefekt SA.100
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Staphefekt SA.100, Placebo
- Keywords
- Atopic dermatitis, Staphylococcus aureus, Microbiome, Staphefekt
- Medical subject headings
- Dermatitis, Atopic, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staphefekt SA.100Device
Also called Gladskin
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Staphefekt SA.100 | Active comparator | Staphefekt SA.100 cream, twice daily on (lesional) skin during 12 weeks Receives: Device: Staphefekt SA.100 |
| Placebo | Placebo comparator | Placebo (Gladskin cream without the Staphefekt protein), twice daily on (lesional) skin during 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks
Measured: baseline, 12 weeks
Secondary outcomes (13)
Difference in mean grams/week topical corticosteroid use between verum and placebo group
Measured: 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
Measured: baseline, 2, 12 and 20 weeks
Change in Eczema Area and Severity Index (EASI) from baseline to week 2, 6, 12 and 20
Measured: baseline, 2, 6, 12 and 20 weeks
Change in Patient Orientated Eczema Measurement (POEM) from baseline to week 2, 6, 12 and 20
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline, 12 and 20 weeks
Number of flares through week 12
Measured: baseline, 12 weeks
Change in Skindex-29 score from baseline to week 12 and week 20
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: baseline, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Micreos, TNO, Regional Public Health Laboratory Kennemerland
- Responsible party
- Principal investigator, Suzanne G.M.A. Pasmans, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840955
- Sponsor's protocol ID
- 2016-233
- Status last verified
- Feb 2018
- First submitted
- 11 Jul 2016
- Last updated
- 23 Feb 2018
- Results posted
- No
Publications
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.
PubMed 28859690
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02840955
- Acronym / sponsor ID
- 2016-233
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Staphylococcus aureus, Microbiome, Staphefekt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Micreos, TNO, Regional Public Health Laboratory Kennemerland
- Study start
- Jun 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staphefekt SA.100 | Active comparator | Device: Staphefekt SA.100Staphefekt SA.100 cream, twice daily on (lesional) skin during 12 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (Gladskin cream without the Staphefekt protein), twice daily on (lesional) skin during 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staphefekt SA.100Also: Gladskin | Device | Staphefekt SA.100 |
| Placebo | Other | Placebo |
Primary outcome
Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks
Time frame: baseline, 12 weeks
13 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 28859690Totte 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staphefekt SA.100 in people with Atopic Dermatitis, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02840955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.