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

Psoriasis Clinical Trial

— Derma-001  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319781
• Other study ID #: H-23038433
• Status: Recruiting
• Start date: December 15, 2023
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Blueskin AS
• Contact: Alejandro Castillo Mondragón, MD
• Phone: +4550376106
• Email: amo[@]nbcd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis
• Vitiligo

Intervention

Other:
• Observational
The study is a prospective non-interventional, observational study.

Locations

Country	Name	City	State
Denmark	Sanos Clinic, Gandrup	Gandrup
Denmark	Sanos Clinic, Herlev	Herlev
Denmark	Sanos Clinic, Vejle	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Blueskin AS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of the disease.	Descriptive changes in relevant disease activity scores over the study period	52 weeks
Primary	Clinical characteristics and disease activity.	Association/correlations of clinical characteristics (age, sex, body-mass index, baseline disease activity score, disease duration etc.) with disease activity/flares	52 weeks
Primary	Tissue profiling and disease activity.	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	52 weeks
Primary	Disease activity and biomarkers.	Associations of patient-reported treatment regimens and disease activity parameters, and relevant parameters derived from serum and skin biopsy biomarkers	52 weeks
Primary	Quality of life.	Changes from baseline in quality of life as analyzed by the WHOQOL-BREF	52 weeks
Primary	Compliance of remote tasks.	Proportional compliance in % with required self-assessments and photo acquisitions during the study period	52 weeks
Primary	Quality of smartphone collected photos.	Proportion of acquired images which were deemed of adequate quality to facilitate remote assessment	52 weeks
Primary	Level of agreement between the in-person and remote scoring	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	52 weeks