Atopic DermatitisClinPRO-DERMNCT05084417
A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions
An observational study of Atopic Dermatitis and Dermatology, run by OM1, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis, Dermatology, Vitiligo
- What is being tested?
- N/A This is an observational study
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 15 Jan 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- N/A This is an observational study
- Keywords
- Registry, Patient Outcomes, Dermatological Conditions
- Medical subject headings
- Dermatitis, Atopic, Vitiligo, Alopecia Areata, Hidradenitis Suppurativa, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A This is an observational studyOther
As this is an observational study, there are no interventions assigned to either cohort.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: N/A This is an observational study | |
| 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. Receives: Other: N/A This is an observational study | |
| 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. Receives: Other: N/A This is an observational study | |
| 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. Receives: Other: N/A This is an observational study | |
| 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. Receives: Other: N/A This is an observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start9 Jun 2023
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- OM1, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Academy of Dermatology
- Responsible party
- Sponsor
- Investigators
- Stefan Weiss, MD, Principal investigator, OM1, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084417
- Sponsor's protocol ID
- OM1-DERM-001
- Acronym
- ClinPRO-DERM
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClinPRO-DERM: A Prospective, Observational Study of Clinician and Patient-reported Outcomes in Patients With Dermatological Conditions
- ClinicalTrials.gov ID
- NCT05084417
- Acronym / sponsor ID
- ClinPRO-DERM / OM1-DERM-001
- Conditions
- Atopic Dermatitis, Dermatology, Vitiligo, Alopecia Areata, Hidradenitis Suppurativa, Psoriasis
- Keywords
- Registry, Patient Outcomes, Dermatological Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- OM1, Inc.Industry (pharma, biotech, devices)
- Collaborators
- American Academy of Dermatology
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Alopecia Areata | – | Other: N/A This is an observational studyCohort 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. |
| Cohort 2: Atopic Dermatitis | – | Other: N/A This is an observational studyCohort 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. |
| Cohort 3: Hidradenitis Suppurativa | – | Other: N/A This is an observational studyCohort 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. |
| Cohort 4: Psoriasis | – | Other: N/A This is an observational studyCohort 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. |
| Cohort 5: Vitiligo | – | Other: N/A This is an observational studyCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A This is an observational studyAs this is an observational study, there are no interventions assigned to either cohort. | Other | Cohort 1: Alopecia Areata, Cohort 2: Atopic Dermatitis, Cohort 3: Hidradenitis Suppurativa, Cohort 4: Psoriasis, Cohort 5: Vitiligo |
Primary outcome
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.
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).
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Weiss, MD principal investigator
OM1, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Dermatology, run by OM1, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall body surface area involvement (%BSA-AD, single score, scored 0-100) (time frame: Baseline to 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.