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)

March 13, 2024 updated by: Blueskin AS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alejandro Castillo Mondragón, MD
  • Phone Number: +4550376106
  • Email: amo@nbcd.com

Study Contact Backup

Study Locations

  • Denmark
      • Gandrup, Denmark, 9362
      • Herlev, Denmark, 2730
        • Recruiting
        • Sanos Clinic, Herlev
        • Contact:
      • Vejle, Denmark, 7100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
The study is a prospective non-interventional, observational study.
Alopecia areata
In addition to all other "basis" assessments, subjects diagnosed with AA are to complete the following forms: SALT and PGIS
Other: Observational
The study is a prospective non-interventional, observational study.
Psoriasis
In addition to all other "basis" assessments, subjects diagnosed with psoriasis are to complete the following forms: PASI, SAPASI, PGA, PLSI
Other: Observational
The study is a prospective non-interventional, observational study.
Vitiligo
In addition to all other "basis" assessments, subjects diagnosed with vitiligo are to complete the following forms: VASI, VETF, and VIDA
Other: Observational
The study is a prospective non-interventional, observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of the disease.
Time Frame: 52 weeks
Descriptive changes in relevant disease activity scores over the study period
52 weeks
Clinical characteristics and disease activity.
Time Frame: 52 weeks
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.
Time Frame: 52 weeks
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.
Time Frame: 52 weeks
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.
Time Frame: 52 weeks
Changes from baseline in quality of life as analyzed by the WHOQOL-BREF
52 weeks
Compliance of remote tasks.
Time Frame: 52 weeks
Proportional compliance in % with required self-assessments and photo acquisitions during the study period
52 weeks
Quality of smartphone collected photos.
Time Frame: 52 weeks
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
Time Frame: 52 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blueskin AS

Investigators

  • Principal Investigator: Zarqa Ali, MD, PhD, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23038433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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