The effect of Gladskin on the disease severity and the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis.

The effect of Gladskin on the disease severity and the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis. - The effect of Gladskin on atopic dermatitis and the skin microbiome.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46056

Enrollment

100

Registered

2016-06-15

Start date

2016-07-12

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermititis eczema

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Difference in number of days/week corticosteroid use between verum and placebo group over 12 weeks.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)