The goal of this study is to evaluate the effect of Gladskin on usage of topical corticosteroids in patients with atopic dermatitis. Secondary goals are to retrieve information about the effect of Gladskin on clinical symptoms, quality of life,…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in number of days/week corticosteroid use between verum and placebo
group over 12 weeks.
Secondary outcome
1. Efficacy:
- Difference in mean grams/week topical corticosteroid use between verum and
placebo group over 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 (appendix 8).
- Change in Eczema Area and Severity Index (EASI) from baseline to week 2, 6,
12 and 20
- Change in Patient Oriented Eczema Measure (POEM) from baseline to week 2, 6,
12 and 20
- Proportion of patients with a reduction from baseline of 2 or more points of
Investigators global assessment (IGA) at week 2, 6 and week 12
- Change in IGA from baseline to week 2, 6 and 12 and week 20
- Change in Pruritus Numerical Rating Scale (Pruritus NRS) from baseline to
week 2, week 6 and week 12 and week 20
- Proportion of patients with a change in Pruritus numerical Rating Scale
(Pruritus NRS) form baseline to week 2, week 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.
2. Quality of Life:
- Change in Skindex-29 score from baseline to week 12 and week 20.
3. The effect of Gladskin on the dynamics of S. aureus and on other
microorganisms on skin/mucosa:
- Proportion of patients with a reduction of S. aureus from baseline to
measurement 1 (0,5hour 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 QPCR
- Change in relative abundance of bacteria: determined by 16s rRNA sequencing
4. Safety and tolerability of Gladskin:
- Incidence of (serious) adverse device events from baseline through the end of
the study.
Background summary
Staphylococcus aureus (S. aureus) is both a commensal and a pathogenic
organism. Carriage of S. aureus is not harmful per se, however the bacteria is
responsible for the vast majority of skin infections, such as impetigo and
infection of wounds. Also colonization with S. aureus is related to atopic
dermatitis. Increasing multidrug resistance of S. aureus points out the need
for development of alternative treatment options. Gladskin is a product for
topical use. The proprietary enzyme in the Gladskin products is called
Staphefekt. Staphefekt specifically lyses the cell wall of S. aureus. In vitro
results showed that Staphefekt kills S. aureus, leaving the commensal flora
intact. Gladskin might decrease S. aureus colonization of the skin and
consequently decrease occurrence of and/or symptoms of S. aureus related
disease.
Study objective
The goal of this study is to evaluate the effect of Gladskin on usage of
topical corticosteroids in patients with atopic dermatitis. Secondary goals are
to retrieve information about the effect of Gladskin on clinical symptoms,
quality of life, growth characteristics of S. aureus and the further
microbiome.
Study design
A multi center intervention study with a placebo controlled, double blind and
randomized design. All patients that fulfill the criteria for in- and exclusion
will be randomized in a 1:1 fashion to topical corticosteroid treatment
(triamcinolone acetonide 0.1%) combined with Gladskin cream or topical
corticosteroid treatment (triamcinolone acetonide 0.1%) combined with a
placebo.
Intervention
Patients with atopic dermatitis of moderate or severe severity will be screened
and characterized. Swabs will be collected of the nares, the pharynx and the
lesional skin and patient characteristics will be evaluated using a
questionnaire addressing e.g. history of skin disease. All patients that
fulfill the criteria for in- and exclusion will be randomized in a 1:1 fashion
to topical corticosteroid treatment (triamcinolone acetonide 0.1%) combined
with Gladskin cream or topical corticosteroid treatment (triamcinolone
acetonide 0.1%) combined with a placebo. Gladskin/Placebo will be used on the
complete skin surface twice daily during 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 burden and risks
Benefit: Participation in this study might result in individual benefit for the
patient, as Gladskin might reduce S. aureus load on the skin. Flares in
patients with eczema are associated with higher loads of S. aureus.
Burden: The study includes 6 visits within 22 weeks. Visits will take
approximately 30 minutes. (Visit 2 will take approximately 1 hour). Screening
for S. aureus is performed using swabs, a non-invasive method.
Risks: The risk of using Gladskin is low. Since endolysins are proteins, they
are inherently non-toxic. Theoretically toxicity can occur when in the
purification process of the lysins a toxic substance of the host bacteria is
co-purified. Staphefekt is tested on purity (host cell contamination and
endotoxin levels) according to European regulations. Staphefekt is a large size
protein molecule (>50kDa) and will not penetrate or pass intact skin. In animal
testing with other endolysins (not Staphefekt) no adverse side effects were
seen. There is a possibility of a contact allergic reaction to other basic
components (cera cetomacrogol) of the product or the swab solution (tween).
Burgemeester s'Jacobplein 51
Rotterdam 3015CA
NL
Burgemeester s'Jacobplein 51
Rotterdam 3015CA
NL
Listed location countries
Age
Inclusion criteria
1. Atopic dermatitis of moderate severity. Defined by EASI score of 7 to 50 performed by the researcher at visit 1.
2. > 18 years old
3. Topical corticosteroid use (of any type).
4. Able to read patient information and provide informed consent
Exclusion criteria
1. Use of systemic antibiotics or corticosteroids within the last 2 months
2. Use of Methotrexate or oral immunosuppressive agents in the last 3 months
3. Use of topical antibiotics in the previous 7 days
4. Use light therapy in the previous 3 months.
5. Use of Gladskin in the previous 7 days
6. Allergy to components of the study drug
7. Clinically infected atopic dermatitis
8. Existence of another skin condition, such as folliculitis psoriasis that could interfere with the assessment of the eczema severity.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02840955 |
| CCMO | NL57362.078.16 |