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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Sanos Clinic, Gandrup
RECRUITING
Gandrup
Sanos Clinic, Herlev
RECRUITING
Herlev
Sanos Clinic, Vejle
RECRUITING
Vejle
Contact Information
Primary
Alejandro Castillo Mondragón, MD
amo@nbcd.com
+4550376106
Backup
Asger Reinstrup Bihlet, PhD
abi@nbcd.com
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2025-05
Participants
Target number of participants: 370
Treatments
Atopic dermatitis
In addition to all other basis assessments, subjects diagnosed with AD are to complete the following forms: EASI, vIGA-AD, SCORAD, TIS, and POEM.
Alopecia areata
In addition to all other basis assessments, subjects diagnosed with AA are to complete the following forms: SALT and PGIS
Psoriasis
In addition to all other basis assessments, subjects diagnosed with psoriasis are to complete the following forms: PASI, SAPASI, PGA, PLSI
Vitiligo
In addition to all other basis assessments, subjects diagnosed with vitiligo are to complete the following forms: VASI, VETF, and VIDA
Sponsors
Leads: Blueskin AS

This content was sourced from clinicaltrials.gov