Brief Summary

The primary goal of the study is to collect standardized patient and clinician reported outcome measures for patients diagnosed with a range of dermatological conditions in an academic clinical practice setting. By regularly measuring outcomes longitudinally in patients treated in a real-world setting, this study will provide valuable and necessary information as to the impact of both the disease and its treatments on patients over time and will inform the optimal clinical management of patients with living with dermatological disease.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

10,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

October 7, 2021

Completed

12 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed

1.6 years until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed

Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

October 7, 2021

Last Update Submit

October 31, 2023

Conditions

Atopic Dermatitis Dermatology Vitiligo Alopecia Areata Hidradenitis Suppurativa Psoriasis

Keywords

RegistryPatient OutcomesDermatological Conditions

Outcome Measures

Primary Outcomes (6)

Overall body surface area involvement (%BSA-AD, single score, scored 0-100)
A simple measure of percent body surface area involved that complements the IGA in providing a relatively quick accurate representation of disease extent and severity.
Baseline to 2 years
Investigator Global Assessment (IGA, scored 0-4; clear, almost clear, mild, moderate, and severe).
A 5-point IGA scale including morphologic descriptions, ranging from 0 (clear) to 4 (severe).
Baseline to 2 years
Dermatology Life Quality Index (DLQI, 10 items, scored 0-30)
The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week
Baseline to 2 years
Work Productivity and Activity Impairment questionnaire (WPAI,-GH v2.0, 6 items)
The questionnaire has four domains: Work Time Missed; Percent Impairment While Working; Percent Overall Work Impairment; and Percent Activity Impairment. Only one domain (Percent Activity Impairment) is completed by patients who are not currently employed
Baseline to 2 years
EuroQoL 5-dimension (EQ-5D; 5 items and a single VAS)
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Baseline to 2 years
Patient Health Questionnaire-2 (PHQ-2, 2 items)
A simple two-item questionnaire evaluating the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks. This survey is intended to screen for potential depression and is not diagnostic
Baseline to 2 years

Study Arms (5)

Cohort 1: Alopecia Areata

Cohort 1 is limited to patients clinically diagnosed with Alopecia Areata. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional AA-specific measures throughout the length of the study.