Table 1.
Items | Screening/run-in period | Visit 1 (baseline) | Visit 2 | Visit 3 | Visit 4 (endpoint) | Visit 5 (follow-up) |
---|---|---|---|---|---|---|
Week of the trial | −2/−1 | 0 | 4 | 8 | 12 | 16 |
Demographic information-taking | + | |||||
Informed consent form (PICF) | + | |||||
General medical history-taking | + | |||||
Severity of AE for inclusion and exclusion of the participants (NESS) | + | |||||
Blood tests | + | + | + | |||
Clinical sign of AE (EASI) | + | + | + | + | + | |
Symptoms (POEM) | + | + | + | + | + | |
QoL score (CDLQI) | + | + | + | + | + | |
Distributions of treatment or placebo products | + | + | + | |||
Daily medical record | + | + | + | + | + | + |
Monitor of adverse event | + | + | + | + | + | |
Compliance check | + | + | + | + | + | |
Survey of participation | + |
Abbreviations: AE atopic eczema, CDLQI Children’s Dermatology Life Quality Index, EASI Eczema Area and Severity Index, NESS Nottingham Eczema Severity Score, PICF participant information and consent form, POEM Patient-Oriented Eczema Measure, QoL quality of life