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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-15

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alopecia Areata Vitiligo Atopic Dermatitis Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No