Alopecia Areata, Atopic Dermatitis, Psoriasis, Vitiligo
Conditions
Brief summary
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.
Interventions
OTHERObservational
The study is a prospective non-interventional, observational study.
Sponsors
Blueskin AS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects \>18 years of age at screening. * Previous diagnosis by a physician of atopic dermatitis, psoriasis, vitiligo, or alopecia areata. * Visible lesions and willingness to photograph weekly using their smartphone * Availability of a smartphone
Exclusion criteria
* Has any physical attributes or skin conditions that in the opinion of the investigator might interfere with the evaluation of lesions (i.e., pigmentation, tattoos, extensive scarring, excessive hair growth or acne) * Has other clinically relevant illness that could interfere with healing of lesions (e.g. keloid scaring) * Current or previous malignant disease, including malignant melanoma and basal cell carcinoma, within 5 years * Some patients may have more than one of the four conditions. This is not an exclusion criterion per se but must be recorded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of the disease. | 52 weeks | Descriptive changes in relevant disease activity scores over the study period |
| Clinical characteristics and disease activity. | 52 weeks | Association/correlations of clinical characteristics (age, sex, body-mass index, baseline disease activity score, disease duration etc.) with disease activity/flares |
| Tissue profiling and disease activity. | 52 weeks | 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 |
| Disease activity and biomarkers. | 52 weeks | Associations of patient-reported treatment regimens and disease activity parameters, and relevant parameters derived from serum and skin biopsy biomarkers |
| Quality of life. | 52 weeks | Changes from baseline in quality of life as analyzed by the WHOQOL-BREF |
| Compliance of remote tasks. | 52 weeks | Proportional compliance in % with required self-assessments and photo acquisitions during the study period |
| Quality of smartphone collected photos. | 52 weeks | Proportion of acquired images which were deemed of adequate quality to facilitate remote assessment |
| Level of agreement between the in-person and remote scoring | 52 weeks | 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 |
Countries
Denmark
Contacts
Primary ContactAlejandro Castillo Mondragón, MD
Backup ContactAsger Reinstrup Bihlet, PhD
Outcome results
None listed