Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319781
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Brief 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
Sponsor:
Blueskin AS
Organization:
Blueskin AS
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Derma-001
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None