The objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. Further, the study aims at validating remote assessments of skin lesions, using smartphone-acquired photos. The study will also assess the feasibility and compliance with weekly remote-assessments and patient-reported data collection over the full study period of one year. The study will observe patients through a period of one year and will provide detailed information concerning the type and dose of medication used, as well as data to evaluate the disease activity with high resolution during this period. The study will involve collection of serum samples for exploratory biomarkers, and punch biopsies. A total of approximately 370 patients, divided into the four disease areas of atopic dermatitis, alopecia areata, psoriasis, and vitiligo, will be enrolled in the study. Using a combination of self-reported and on-site assessments and procedures, the intent is to observe the natural history of patients with select dermatological conditions, investigate tissue characteristics associated with disease activity and symptoms, and evaluate the validity of remote assessment of lesions, and feasibility of weekly self-acquired smart-phone images of skin lesions for remote assessment.
Study Type
OBSERVATIONAL
Enrollment
370
The study is a prospective non-interventional, observational study.
Sanos Clinic, Gandrup
Gandrup, Denmark
RECRUITINGSanos Clinic, Herlev
Herlev, Denmark
RECRUITINGSanos Clinic, Vejle
Vejle, Denmark
RECRUITINGSeverity of the disease.
Descriptive changes in relevant disease activity scores over the study period
Time frame: 52 weeks
Clinical characteristics and disease activity.
Association/correlations of clinical characteristics (age, sex, body-mass index, baseline disease activity score, disease duration etc.) with disease activity/flares
Time frame: 52 weeks
Tissue profiling and disease activity.
Changes in tissue profiling and associations with disease activity based on relevant analyses of skin punch biopsies and standard disease activity scoring scales as listed below
Time frame: 52 weeks
Disease activity and biomarkers.
Associations of patient-reported treatment regimens and disease activity parameters, and relevant parameters derived from serum and skin biopsy biomarkers
Time frame: 52 weeks
Quality of life.
Changes from baseline in quality of life as analyzed by the WHOQOL-BREF
Time frame: 52 weeks
Compliance of remote tasks.
Proportional compliance in % with required self-assessments and photo acquisitions during the study period
Time frame: 52 weeks
Quality of smartphone collected photos.
Proportion of acquired images which were deemed of adequate quality to facilitate remote assessment
Time frame: 52 weeks
Level of agreement between the in-person and remote scoring
Level of agreement between the in-person and remote scoring, inter- and intrareliability, subsequent bias (average of differences) and precision estimates on the average difference between the scorings evaluated by the raters from remote and in-person, from the changes from baseline in relevant disease activity scores
Time frame: 52 weeks
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