A 4 week, open label, multi-centre (GP setting), post market clinical follow-up study with Doublebase Once in patients of any age and any severity of atopic eczema.
The study will involve patients who are already using emollients as part of their treatment regime, switching to Doublebase Once. Patients will ideally apply the product once daily for 4 weeks and SCORAD assessments will be performed, and patient questionnaires will be completed. A subgroup of adult patients (up to 15 patients) will also undergo skin hydration measurements for the first 8 days to evaluate objective measurements of skin hydration in patients with atopic eczema.
Photographs of the same, representative area of eczema will also be taken for all patients at baseline and after 4 weeks of using Doublebase Once.
ii) Patients with atopic eczema (personal history or combined personal and familial atopy), of any severity in accordance with the NICE categorisation set out in the table below.
None
Single group
Doublebase Once
DeviceEmollient
Change from baseline in SCORAD after 4 weeks of treatment
The SCORAD scoring is described in section 7.4.1. For each patient, a score will be obtained at baseline, after 4 weeks. The minimum score is 0 (best outcome) and the maximum score is 103 (worst outcome). The change score will be calculated by subtracting the baseline score from the score after 4 weeks. The actual scores after 4 weeks and the change from baseline will be summarised using summary statistics. In addition, the change from baseline will be presented with a 95% confidence interval (CI), and the following hypotheses will be tested at the two-sided 5% significance level using a paired t-test. The SCORAD score is from 0-103 and there is a minimum score of 15 at inclusion. A reduction in total score represents an improvement in the overall condition.
Change from baseline in SCORAD after 1 week of treatment.
The change from baseline in SCORAD after 1 week of treatment will be summarised and analysed in the same way as the primary endpoint. The SCORAD score is from 0-103 and there is a minimum score of 15 at inclusion. A reduction in total score represents an improvement in the overall condition.
SCORAD individual items
Individual items of the SCORAD will be summarised using descriptive statistics (frequencies for categorical items and summary statistics for continuous measures). These items will be formally evaluated using inferential statistics by comparing values after weeks 1 and 4 versus baseline. The redness, dryness and swelling scores at week 4 will be compared to baseline using an ordinal logistic regression model for paired data. The odds of being in a better outcome category post-treatment compared to pre-treatment will be calculated with a 95% CI and p-value. The itch and sleeplessness scores post-treatment will be compared to the pre-treatment value using a paired t-test, or a Wilcoxon signed rank test if assumptions of Normality are violated. Change from baseline itch and sleeplessness (separately) will be presented with a 95% CI.
Patient Questionnaire
For each of the five quality of life questions and for the sum score from the five questions, the score post-treatment will be compared to the pre-treatment value using a paired t-test. The Patient Questionnaire (QoL) score is calculated at baseline and a reduction in total score overall represents a Patient perceived improvement in the overall condition.
Skin Hydration
Skin hydration assessments will be performed in up to 15 adults and are a subgroup of the main study. The corneometry values at each visit and the change from baseline will be summarised using summary statistics. The area under the curve (AUC) over the assessment period up to Day 8 will be calculated using the trapezoidal rule.
Correlation between SCORAD and corneometry
The correlation between change from baseline in SCORAD and change from baseline in corneometry will be assessed in the skin hydration subgroup using the values recorded on Day 8. The Spearmank rank correlation will be calculated.
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Dermal Laboratories Ltd
Lead sponsor
Nottingham University Hospitals NHS Trust
Collaborator
Sherwood Forest Hospitals NHS Foundation Trust
Collaborator
