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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03661866
Other study ID # TARGET-DERM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2018
Est. completion date December 2050

Study information

Verified date March 2024
Source Target PharmaSolutions, Inc.
Contact Laura Dalfonso
Phone 9842340268
Email ldalfonso@targetrwe.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15000
Est. completion date December 2050
Est. primary completion date December 2050
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Locations

Country Name City State
Canada Innovaderm Research, Inc. Montréal Quebec
Canada Skin Centre for Dermatology Peterborough Ontario
Canada York Dermatology Clinic and Research Centre Richmond Hill Ontario
Canada Saskatoon Dermatology Centre Saskatoon Saskatchewan
Germany Dr. Bernhard Korge Düren NRW
Germany UKSH- Institut für Entzündungsmedizin Lübeck Schleswig-Holstein
Germany Dermatologische Gemeinschaftspraxis Mahlow Mahlow Bradenburg
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital Universitario La Princesa Madrid
United States Allergy Partners of Western North Carolina Asheville North Carolina
United States Montefiore Medical Center Bronx New York
United States Centurion Dermatology Brooklyn New York
United States The University of Buffalo Buffalo New York
United States UNC Dermatology Chapel Hill North Carolina
United States The Medical University of South Carolina Charleston South Carolina
United States Lurie Children's Hospital/Northwestern University Chicago Illinois
United States Ohio State University Columbus Ohio
United States Empire Dermatology East Syracuse New York
United States Windsor Dermatology East Windsor New Jersey
United States El Paso Dermatology Center El Paso Texas
United States Forest Hills Dermatology Group Forest Hills New York
United States Johnson Dermatology Fort Smith Arkansas
United States First OC Dermatology Fountain Valley California
United States Center for Dermatology Cosmetic and Laser Surgery Fremont California
United States North Texas Center for Clinical Research Frisco Texas
United States Feinstein Dermatology and Cosmetic Surgery Hollywood Florida
United States Dawes Fretzin Dermatology/ Dawes Fretzin Clinical Research Group Indianapolis Indiana
United States University of California Irvine California
United States The University of Kansas Medical Center Kansas City Kansas
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States Asthma and Allergy Center Lewisville Texas
United States South Lincoln Dermatology Clinic Lincoln Nebraska
United States Arkansas Dermatology Little Rock Arkansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Family Allergy and Asthma Research Institute Louisville Kentucky
United States North Sound Dermatology Mill Creek Washington
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Carl Thornblade, MD, PLLC Missoula Montana
United States Dermatology Center for Skin Health Morgantown West Virginia
United States Allergy Associates of Utah Murray Utah
United States University of Utah MidValley Dermatology Murray Utah
United States Greenwich Village Dermatology New York New York
United States Ichan School of Medicine New York New York
United States Allergy, Asthma & Clinical Research Center Oklahoma City Oklahoma
United States Advanced Dermatology of the Midlands Omaha Nebraska
United States Allergy and Clinical Immunology Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Integrated Dermatology of Massachusetts Quincy Massachusetts
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States DermAssociates, LCC Rockville Maryland
United States Advanced Allergy & Asthma, PLLC Rockville Centre New York
United States University of California - San Diego/Rady Children's Hospital San Diego California
United States Clear Dermatology & Aesthetics Center/Investigative MD Scottsdale Arizona
United States Spokane Dermatology Clinic Spokane Washington
United States Academic Alliance in Dermatology Tampa Florida
United States George Washington University Washington District of Columbia
United States Center for Clinical Studies Webster Texas
United States Integrated Dermatology of West Palm Beach West Palm Beach Florida
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States University of Massachusetts Medical School Worcester Massachusetts
United States Linda Susan Marcus Wyckoff New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Target PharmaSolutions, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Characterize IMISC Treatment Regimens in Clinical Practice Enable characterization of IMISC disease activity and comorbid medical conditions over time. 25 Years
Primary Evaluate Patient Outcomes in Clinical Practice Enable characterization of IMISC disease activity and comorbid medical conditions over time. 25 Years
Primary 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 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
Secondary 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
Secondary 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
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