A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo (Derma-001)

Blueskin AS

Status: Enrolling

Conditions: Atopic Dermatitis; Psoriasis; Vitiligo; Alopecia Areata

Treatments: Other: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT06319781

H-23038433

Details and patient eligibility

About

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.

Enrollment: 370 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

370 participants in 4 patient groups

Atopic dermatitis

Description:

In addition to all other "basis" assessments, subjects diagnosed with AD are to complete the following forms: EASI, vIGA-AD, SCORAD, TIS, and POEM.

Treatment:

Other: Observational

Alopecia areata

Description:

In addition to all other "basis" assessments, subjects diagnosed with AA are to complete the following forms: SALT and PGIS

Treatment:

Other: Observational

Psoriasis

Description:

In addition to all other "basis" assessments, subjects diagnosed with psoriasis are to complete the following forms: PASI, SAPASI, PGA, PLSI

Treatment:

Other: Observational

Vitiligo

Description:

In addition to all other "basis" assessments, subjects diagnosed with vitiligo are to complete the following forms: VASI, VETF, and VIDA

Treatment:

Other: Observational