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

NCT06319781 | Recruiting

• 1 other identifier: H-23038433
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 3

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.

Conditions

Alopecia Areata; Vitiligo; Atopic Dermatitis; Psoriasis

Outcome Measures

Primary Outcomes (8)

• Severity of the disease.

  Descriptive changes in relevant disease activity scores over the study period

  52 weeks

• 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

• 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

• 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

• Quality of life.

  Changes from baseline in quality of life as analyzed by the WHOQOL-BREF

  52 weeks

• Compliance of remote tasks.

  Proportional compliance in % with required self-assessments and photo acquisitions during the study period

  52 weeks

• Quality of smartphone collected photos.

  Proportion of acquired images which were deemed of adequate quality to facilitate remote assessment

  52 weeks

• 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

Study Arms (4)

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.

Other: Observational

Alopecia areata

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

Other: Observational

Psoriasis

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

Other: Observational

Vitiligo

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

Other: Observational

Interventions

Observational OTHER

The study is a prospective non-interventional, observational study.

Alopecia areata; Atopic dermatitis; Psoriasis; Vitiligo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Minimum 18 years of age with either Atopic dermatitis, Alopecia areata, Psoriasis or Vitiligo.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blueskin AS: lead

Study Sites (3)

Sanos Clinic, Gandrup

Gandrup, 9362, Denmark

RECRUITING

Sanos Clinic, Herlev

Herlev, 2730, Denmark

RECRUITING

Sanos Clinic, Vejle

Vejle, 7100, Denmark

RECRUITING

MeSH Terms

Conditions

Alopecia Areata; Vitiligo; Dermatitis, Atopic; Psoriasis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Hypopigmentation; Pigmentation Disorders; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Zarqa Ali, MD, PhD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Castillo Mondragón, MD

CONTACT

+4550376106; amo@nbcd.com

Asger Reinstrup Bihlet, PhD

CONTACT

abi@nbcd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: December 15, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)