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

October 31, 2023 updated by: OM1, Inc.

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • OM1

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (defined as at least the age of majority in their state or older) who have received a clinical diagnosis of alopecia areata, atopic dermatitis, hidradenitis suppurativa, psoriasis, or vitiligo.

Description

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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.
Cohort 2: Atopic Dermatitis
Cohort 2 is comprised of patients that have been clinically diagnosed with Atopic Dermatitis. Patients in this cohort will receive the universal PROs and ClinROs, but will also receive additional AD-specific measures throughout the length of the study.
Other: N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.
Cohort 3: Hidradenitis Suppurativa
Cohort 3 is limited to patients clinically diagnosed with Hidradenitis Suppurativa. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional HS-specific measures throughout the length of the study.
Other: N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.
Cohort 4: Psoriasis
Cohort 4 is limited to patients clinically diagnosed with Psoriasis. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional PsO-specific measures throughout the length of the study.
Other: N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.
Cohort 5: Vitiligo
Cohort 5 is limited to patients clinically diagnosed with Vitiligo. Patients in this cohort will receive the universal ClinROs and PROs (i.e. not disease specific) as well as additional VL-specific measures throughout the length of the study.
Other: N/A This is an observational study
As this is an observational study, there are no interventions assigned to either cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall body surface area involvement (%BSA-AD, single score, scored 0-100)
Time Frame: Baseline to 2 years
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).
Time Frame: Baseline to 2 years
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)
Time Frame: Baseline to 2 years
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)
Time Frame: Baseline to 2 years
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)
Time Frame: Baseline to 2 years
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)
Time Frame: Baseline to 2 years
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

Collaborators and Investigators

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

Sponsor

OM1, Inc.

Collaborators

American Academy of Dermatology

Investigators

  • Principal Investigator: Stefan Weiss, MD, OM1, Inc.

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)

June 9, 2023

Primary Completion (Estimated)

January 15, 2026

Study Completion (Estimated)

January 15, 2026

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OM1-DERM-001

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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