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

Psoriasis Clinical Trial

— ClinPRO-DERM  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05084417
• Other study ID #: OM1-DERM-001
• Status: Enrolling by invitation
• Start date: June 9, 2023
• Est. completion date: January 15, 2026

Study information

• Verified date: October 2023
• Source: OM1, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (defined as the age of majority in their state of residence or older) at enrollment

• Able to read and communicate in English

• Have a smart phone or other internet enabled device capable of PRO data collection

• Diagnosed with a qualifying, clinically confirmed, diagnosis of a study condition in the judgement of the treating physician at presentation

• Willing and able to provide informed consent

• Willing to participate in the collection of patient-reported outcomes for up to two years

Exclusion Criteria:

• Current (or planned) participation in an interventional clinical trial where treatment and/or management of any of the study conditions is being dictated by a protocol.

• Patient is not expected to be actively followed (i.e., seen at least annually as part of routine care) at the site for the duration of the follow-up period.

Related Conditions & MeSH terms

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

Intervention

Other:
• N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.

Locations

Country	Name	City	State
United States	OM1	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
OM1, Inc.	American Academy of Dermatology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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