- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661866
A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC (TARGET-DERM)
A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Ontario
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Peterborough, Ontario, Canada
- Skin Centre for Dermatology
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Richmond Hill, Ontario, Canada, L4B 1L1
- York Dermatology Clinic and Research Centre
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Quebec
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Montreal, Quebec, Canada
- Innovaderm Research, Inc.
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Saskatoon Dermatology Centre
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North Rhine-Westphalia
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Düren, North Rhine-Westphalia, Germany, 52349
- Dr. Bernhard Korge
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- UKSH- Institut für Entzündungsmedizin
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Barcelona, Spain
- Hospital Clinic de Barcelona
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Madrid, Spain
- Hospital Universitario La Princesa
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Arizona
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Scottsdale, Arizona, United States, 85255
- Clear Dermatology & Aesthetics Center/Investigative MD
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Arkansas
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Fort Smith, Arkansas, United States, 72916
- Johnson Dermatology
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72223
- Arkansas Dermatology
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California
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Fountain Valley, California, United States, 92708
- First OC Dermatology
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Fremont, California, United States, 94538
- Center For Dermatology Cosmetic and Laser Surgery
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Irvine, California, United States, 92697
- University of California
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San Diego, California, United States, 92123
- University of California - San Diego/Rady Children's Hospital
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District of Columbia
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Washington D.C., District of Columbia, United States, 20037
- George Washington University
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Florida
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Hollywood, Florida, United States, 33021
- Feinstein Dermatology and Cosmetic Surgery
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Tampa, Florida, United States, 33614
- Academic Alliance in Dermatology
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West Palm Beach, Florida, United States, 33406
- Integrated Dermatology of West Palm Beach
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Illinois
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Chicago, Illinois, United States, 60611
- Lurie Children's Hospital/Northwestern University
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Indiana
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Indianapolis, Indiana, United States, 46520
- Dawes Fretzin Dermatology/ Dawes Fretzin Clinical Research Group
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Kansas
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Kansas City, Kansas, United States, 66160
- The University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40215
- Family Allergy and Asthma Research Institute
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Maryland
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Rockville, Maryland, United States, 20850
- DermAssociates, LCC
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Massachusetts
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Quincy, Massachusetts, United States, 02169
- Integrated Dermatology of Massachusetts
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Worcester, Massachusetts, United States, 01605
- University of Massachusetts Medical School
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Montana
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Missoula, Montana, United States, 59808
- Carl Thornblade, MD, PLLC
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Nebraska
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Lincoln, Nebraska, United States, 68502
- South Lincoln Dermatology Clinic
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Omaha, Nebraska, United States, 68144
- Advanced Dermatology of the Midlands
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth-Hitchcock Medical Center
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New Jersey
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East Windsor, New Jersey, United States, 08520
- Windsor Dermatology
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Wyckoff, New Jersey, United States, 07481
- Linda Susan Marcus
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New York
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Brooklyn, New York, United States, 11219
- Centurion Dermatology
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Buffalo, New York, United States, 14203
- The University of Buffalo
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East Syracuse, New York, United States, 13057
- Empire Dermatology
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Forest Hills, New York, United States, 11375
- Forest Hills Dermatology Group
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New York, New York, United States, 10012
- Greenwich Village Dermatology
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New York, New York, United States, 10029
- Ichan School of Medicine
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Rockville Centre, New York, United States, 11570
- Advanced Allergy & Asthma, PLLC
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The Bronx, New York, United States, 10467
- Montefiore Medical Center
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North Carolina
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Asheville, North Carolina, United States, 28801
- Allergy Partners of Western North Carolina
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Chapel Hill, North Carolina, United States, 27516
- UNC Dermatology
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Ohio
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Columbus, Ohio, United States, 43215
- Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73120
- Allergy, Asthma & Clinical Research Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15241
- Allergy and Clinical Immunology
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South Carolina
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Charleston, South Carolina, United States, 29425
- The Medical University of South Carolina
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Texas
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El Paso, Texas, United States, 79902
- El Paso Dermatology Center
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Frisco, Texas, United States, 75034
- North Texas Center for Clinical Research
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Lewisville, Texas, United States, 75067
- Asthma and Allergy Center
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Webster, Texas, United States, 77598
- Center for Clinical Studies
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Utah
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Murray, Utah, United States, 84107
- Allergy Associates of Utah
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Murray, Utah, United States, 84107
- University of Utah MidValley Dermatology
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Virginia
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Richmond, Virginia, United States, 23219
- Virginia Commonwealth University
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Washington
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Mill Creek, Washington, United States, 98012
- North Sound Dermatology
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Spokane, Washington, United States, 99202
- Spokane Dermatology Clinic
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West Virginia
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Morgantown, West Virginia, United States, 26542
- Dermatology Center for Skin Health
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterize IMISC Treatment Regimens in Clinical Practice
Time Frame: 25 Years
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Enable characterization of IMISC disease activity and comorbid medical conditions over time.
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25 Years
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Evaluate Patient Outcomes in Clinical Practice
Time Frame: 25 Years
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Enable characterization of IMISC disease activity and comorbid medical conditions over time.
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25 Years
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Evaluate Adverse Events of IMISC and treatment in Clinical Practice
Time Frame: 25 Years
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Enable characterization of IMISC disease activity and comorbid medical conditions over time.
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25 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluate the relationship between IMISC and comorbid medical conditions
Time Frame: 25 Years
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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.
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25 Years
|
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Evaluate Patient Reported Outcome (PRO) measures
Time Frame: 25 Years
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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.
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25 Years
|
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Evaluate outcomes related to Patient Support Programs (PSPs)
Time Frame: 25 Years
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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.
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25 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Laura Dalfonso, Target RWE
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Genetic Diseases, Inborn
- Immune System Diseases
- Infections
- Hypersensitivity, Immediate
- Hypersensitivity
- Skin Diseases, Papulosquamous
- Skin Diseases
- Alopecia
- Hypotrichosis
- Hair Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Urticaria
- Skin Diseases, Vascular
- Sweat Gland Diseases
- Skin Diseases, Bacterial
- Skin Diseases, Infectious
- Suppuration
- Hypopigmentation
- Pigmentation Disorders
- Skin Diseases, Genetic
- Skin Diseases, Eczematous
- Dermatitis
- Hidradenitis
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Chronic Urticaria
- Alopecia Areata
- Hidradenitis Suppurativa
- Vitiligo
- Psoriasis
- Dermatitis, Atopic
Other Study ID Numbers
- TARGET-DERM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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