A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

Study Overview
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Brief Summary
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TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Detailed Description
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TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies. The duration of follow-up for participants enrolled in the EU is limited to 5-years. Those within in US and Canada may consent to indefinite follow-up.

Official Title
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A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

Conditions
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Atopic Dermatitis, Alopecia Areata, Hidradenitis Suppurativa, Vitiligo, Psoriasis, Chronic Spontaneous Urticaria

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Adults and children (all ages) with Atopic Dermatitis or other Immune-mediated Inflammatory Skin Conditions been prescribed any dermatologic treatment. 2. Participant has plans for future visits at the site for continued management of IMISC. Exclusion Criteria: 1. Inability to provide written informed consent/assent. 2. Subjects participating in any interventional study or trial for IMISC treatment trial at the time of enrollment. Patients may be enrolled in TARGET-DERM once participation in the trial is complete. Note: Participants may be enrolled in other registries or studies where IMISC treatment outcomes are observed and/or reported (such as center-based registries).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize IMISC Treatment Regimens in Clinical Practice | Enable characterization of IMISC disease activity and comorbid medical conditions over time. | 25 Years | 
| Evaluate Patient Outcomes in Clinical Practice | Enable characterization of IMISC disease activity and comorbid medical conditions over time. | 25 Years | 
| Evaluate Adverse Events of IMISC and treatment in Clinical Practice | Enable characterization of IMISC disease activity and comorbid medical conditions over time. | 25 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the relationship between IMISC and comorbid medical conditions | Inform clinical practice by identifying the occurrence and impact of comorbid medical conditions on treatment regimens, utilize patient reported outcomes, and evaluate patient support programs. | 25 Years | 
| Evaluate Patient Reported Outcome (PRO) measures | Inform clinical practice by identifying the occurrence and impact of comorbid medical conditions on treatment regimens, utilize patient reported outcomes, and evaluate patient support programs. | 25 Years | 
| Evaluate outcomes related to Patient Support Programs (PSPs) | Inform clinical practice by identifying the occurrence and impact of comorbid medical conditions on treatment regimens, utilize patient reported outcomes, and evaluate patient support programs. | 25 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, IMISC, Registry, Observational, Immune-mediated Inflammatory Skin Conditions