NCT05084417

A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions

ClinPRO-DERM: A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: OM1, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a multi-center, longitudinal, observational study to describe longitudinal trajectories of Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) in patients with select dermatological conditions. This study will collect data using validated clinical instruments and patient-reported data on the disease course of alopecia areata (AA), atopic dermatitis (AD), hidradenitis suppurativa (HS), psoriasis (PsO), and vitiligo (VL), including symptom assessments and quality of life (QoL) measures from a patient perspective, to supplement routine clinical data collected from their healthcare providers. ClinRO data will be collected at baseline and routine follow-up visits for up to two years. PRO data will be collected directly from patients at baseline and at pre-specified follow-up time points (as defined in Tables 1 - 2e) for up to two years. The objectives of this study are: * To describe longitudinal changes in disease activity, symptom control and both physical and mental HrQoL based on both ClinROs and PROs * To identify patient, disease and treatment factors associated with changes in PROs over time * To describe the association between PROs, ClinROs and clinical outcomes

Conditions

• Atopic Dermatitis
• Dermatology
• Vitiligo
• Alopecia Areata
• Hidradenitis Suppurativa
• Psoriasis

Interventions

Type	Name	Description
OTHER	N/A This is an observational study	As this is an observational study, there are no interventions assigned to either cohort.

Timeline

• Start date: 2023-06-09
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2021-10-19
• Last updated: 2023-11-01

Locations

1 site across 1 country: United States