A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

Recruiting

• Conditions: Alopecia Areata; Psoriasis; Chronic Spontaneous Urticaria; Atopic Dermatitis; Hidradenitis Suppurativa; Vitiligo

• Registration Number: NCT03661866
• Lead Sponsor: Target PharmaSolutions, Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-07
• Study Start: 2018-12-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2050-12
• Study Completion: 2050-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate Adverse Events of IMISC and treatment in Clinical Practice	25 Years	Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Characterize IMISC Treatment Regimens in Clinical Practice	25 Years	Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Evaluate Patient Outcomes in Clinical Practice	25 Years	Enable characterization of IMISC disease activity and comorbid medical conditions over time.

Secondary Outcome Measures

Name	Time	Method
Evaluate Patient Reported Outcome (PRO) measures	25 Years	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.
Evaluate outcomes related to Patient Support Programs (PSPs)	25 Years	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.
Evaluate the relationship between IMISC and comorbid medical conditions	25 Years	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.

Trial Locations

Locations (63)

Clear Dermatology & Aesthetics Center/Investigative MD; 🇺🇸 Scottsdale, Arizona, United States

Johnson Dermatology; 🇺🇸 Fort Smith, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Arkansas Dermatology; 🇺🇸 Little Rock, Arkansas, United States

First OC Dermatology; 🇺🇸 Fountain Valley, California, United States

Center for Dermatology Cosmetic and Laser Surgery; 🇺🇸 Fremont, California, United States

University of California; 🇺🇸 Irvine, California, United States

University of California - San Diego/Rady Children's Hospital; 🇺🇸 San Diego, California, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Feinstein Dermatology and Cosmetic Surgery; 🇺🇸 Hollywood, Florida, United States

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