Clinical trial NCT06319781: A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo
Official title: A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo / Et Pilot-kohortestudie om Risikofaktorer og Nye Metoder Til at Vurdere hudlæsioner Hos Voksne Med Atopisk Dermatitis, Alopecia Areata, Psoriasis Eller Vitiligo
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alopecia Areata
Vitiligo
Atopic Dermatitis
Psoriasis
Lead sponsor: Blueskin AS
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minimum 18 years of age with either Atopic dermatitis, Alopecia areata, Psoriasis or Vitiligo.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Severity of the disease.
timeFrame: 52 weeks
measure: Clinical characteristics and disease activity.
timeFrame: 52 weeks
measure: Tissue profiling and disease activity.
timeFrame: 52 weeks
measure: Disease activity and biomarkers.
timeFrame: 52 weeks
measure: Quality of life.
timeFrame: 52 weeks
measure: Compliance of remote tasks.
timeFrame: 52 weeks
measure: Quality of smartphone collected photos.
timeFrame: 52 weeks
measure: Level of agreement between the in-person and remote scoring
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gandrup
country: Denmark
facility: Sanos Clinic, Gandrup
city: Herlev
country: Denmark
facility: Sanos Clinic, Herlev
city: Vejle
country: Denmark
facility: Sanos Clinic, Vejle
Study officials:
affiliation: Bispebjerg Hospital
name: Zarqa Ali, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: