A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo
- Conditions
- Atopic DermatitisPsoriasisAlopecia AreataVitiligo
- Interventions
- Other: Observational
- Registration Number
- NCT06319781
- Lead Sponsor
- Blueskin AS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 370
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Psoriasis Observational In addition to all other "basis" assessments, subjects diagnosed with psoriasis are to complete the following forms: PASI, SAPASI, PGA, PLSI Alopecia areata Observational In addition to all other "basis" assessments, subjects diagnosed with AA are to complete the following forms: SALT and PGIS Atopic dermatitis Observational In addition to all other "basis" assessments, subjects diagnosed with AD are to complete the following forms: EASI, vIGA-AD, SCORAD, TIS, and POEM. Vitiligo Observational In addition to all other "basis" assessments, subjects diagnosed with vitiligo are to complete the following forms: VASI, VETF, and VIDA
- Primary Outcome Measures
Name Time Method 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
Compliance of remote tasks. 52 weeks Proportional compliance in % with required self-assessments and photo acquisitions during the study period
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
Severity of the disease. 52 weeks Descriptive changes in relevant disease activity scores over the study period
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
Quality of life. 52 weeks Changes from baseline in quality of life as analyzed by the WHOQOL-BREF
Quality of smartphone collected photos. 52 weeks Proportion of acquired images which were deemed of adequate quality to facilitate remote assessment
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Sanos Clinic, Gandrup
🇩🇰Gandrup, Denmark
Sanos Clinic, Herlev
🇩🇰Herlev, Denmark
Sanos Clinic, Vejle
🇩🇰Vejle, Denmark