A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC (TARGET-DERM)

March 19, 2024 updated by: Target PharmaSolutions, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Peterborough, Ontario, Canada
      • Richmond Hill, Ontario, Canada, L4C 9M7
        • Recruiting
        • York Dermatology Clinic and Research Centre
        • Contact:
        • Principal Investigator:
          • Michael Cecchini, MD
    • Quebec
      • Montréal, Quebec, Canada
        • Recruiting
        • Innovaderm Research, Inc.
        • Contact:
        • Principal Investigator:
          • Robert Bissonnette, MD
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Recruiting
        • Saskatoon Dermatology Centre
        • Contact:
        • Principal Investigator:
          • Kyle Cullingham, MD
  • Germany
    • Bradenburg
      • Mahlow, Bradenburg, Germany, 15831
        • Withdrawn
        • Dermatologische Gemeinschaftspraxis Mahlow
    • NRW
      • Düren, NRW, Germany, 52349
        • Recruiting
        • Dr. Bernhard Korge
        • Contact:
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • UKSH- Institut für Entzündungsmedizin
        • Contact:
        • Principal Investigator:
          • Diamant Thaci, MD,PhD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
        • Principal Investigator:
          • Jose Riera-Monroig
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Princesa
        • Contact:
        • Principal Investigator:
          • Raquel Navarro Tejedor
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Terminated
        • Clear Dermatology & Aesthetics Center/Investigative MD
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Recruiting
        • Johnson Dermatology
        • Contact:
        • Principal Investigator:
          • Sandra Johnson, MD
      • Little Rock, Arkansas, United States, 72205
        • Terminated
        • University of Arkansas for Medical Sciences
      • Little Rock, Arkansas, United States, 72223
        • Recruiting
        • Arkansas Dermatology
        • Contact:
        • Principal Investigator:
          • Matt Reynolds, PA-C
    • California
      • Fountain Valley, California, United States, 92708
      • Fremont, California, United States, 94538
        • Terminated
        • Center For Dermatology Cosmetic and Laser Surgery
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California
        • Contact:
        • Principal Investigator:
          • Natasha Mesinkovska, MD
      • San Diego, California, United States, 92123
        • Recruiting
        • University of California - San Diego/Rady Children's Hospital
        • Principal Investigator:
          • Lawrence F Eichenfield, MD
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • George Washington University
        • Principal Investigator:
          • Jonathan Silverberg, MD, PhD
        • Contact:
    • Florida
      • Hollywood, Florida, United States, 33021
        • Terminated
        • Feinstein Dermatology and Cosmetic Surgery
      • Tampa, Florida, United States, 33614
        • Terminated
        • Academic Alliance in Dermatology
      • West Palm Beach, Florida, United States, 33406
        • Terminated
        • Integrated Dermatology of West Palm Beach
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital/Northwestern University
        • Contact:
        • Principal Investigator:
          • Amy Paller, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46520
        • Recruiting
        • Dawes Fretzin Dermatology/ Dawes Fretzin Clinical Research Group
        • Contact:
        • Principal Investigator:
          • Kenneth W Dawes, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Selina Gierer, DO
    • Kentucky
      • Louisville, Kentucky, United States, 40215
        • Recruiting
        • Family Allergy and Asthma Research Institute
        • Contact:
        • Principal Investigator:
          • James W Sublett, MD
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • DermAssociates, LCC
        • Contact:
        • Principal Investigator:
          • Benjamin Lockshin, MD
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Terminated
        • Integrated Dermatology of Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Terminated
        • University of Massachusetts Medical School
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Maria Hordinsky, MD
        • Contact:
      • Rochester, Minnesota, United States, 55905
        • Terminated
        • Mayo Clinic
    • Montana
      • Missoula, Montana, United States, 59808
        • Recruiting
        • Carl Thornblade, MD, PLLC
        • Contact:
        • Principal Investigator:
          • Carl Thornblade, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Terminated
        • South Lincoln Dermatology Clinic
      • Omaha, Nebraska, United States, 68144
        • Terminated
        • Advanced Dermatology of the Midlands
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Michael S Chapman, MD
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Recruiting
        • Windsor Dermatology
        • Contact:
        • Principal Investigator:
          • Jerry Bagel, MD
      • Wyckoff, New Jersey, United States, 07481
        • Terminated
        • Linda Susan Marcus
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • Holly Kanavy, DO
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Centurion Dermatology
        • Contact:
        • Principal Investigator:
          • Henry Yu
      • Buffalo, New York, United States, 14203
        • Terminated
        • The University of Buffalo
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Empire Dermatology
        • Contact:
        • Principal Investigator:
          • Jeffrey Cizenski, MD
      • Forest Hills, New York, United States, 11375
        • Recruiting
        • Forest Hills Dermatology Group
        • Contact:
        • Principal Investigator:
          • Jeffrey Weinberg, MD
      • New York, New York, United States, 10012
        • Recruiting
        • Greenwich Village Dermatology
        • Contact:
        • Principal Investigator:
          • Andrew J Peranteau, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Ichan School of Medicine
        • Contact:
        • Principal Investigator:
          • Emma Guttman, MD, PhD
      • Rockville Centre, New York, United States, 11570
        • Terminated
        • Advanced Allergy & Asthma, PLLC
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Recruiting
        • Allergy Partners of Western North Carolina
        • Principal Investigator:
          • David Cypcar, MD
        • Contact:
      • Chapel Hill, North Carolina, United States, 27516
        • Recruiting
        • UNC Dermatology
        • Principal Investigator:
          • Donna Culton, MD
        • Contact:
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
        • Principal Investigator:
          • Steven R Feldman, MD
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Ohio State University
        • Contact:
        • Principal Investigator:
          • Benjamin Kaffenberger, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Terminated
        • Allergy, Asthma & Clinical Research Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
        • Principal Investigator:
          • Eric Simpson, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Recruiting
        • Allergy and Clinical Immunology
        • Contact:
        • Principal Investigator:
          • Michael Palumbo, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • The Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Lara Wine Lee, MD
    • Texas
      • El Paso, Texas, United States, 79902
        • Recruiting
        • El Paso Dermatology Center
        • Contact:
        • Principal Investigator:
          • Brenda Simpson, MD
      • Frisco, Texas, United States, 75034
        • Terminated
        • North Texas Center for Clinical Research
      • Lewisville, Texas, United States, 75067
        • Terminated
        • Asthma and Allergy Center
      • Webster, Texas, United States, 77598
        • Terminated
        • Center For Clinical Studies
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Allergy Associates of Utah
        • Contact:
        • Principal Investigator:
          • Andrew M Smith, MD
      • Murray, Utah, United States, 84107
        • Recruiting
        • University of Utah MidValley Dermatology
        • Contact:
        • Principal Investigator:
          • Jamie Rhoads, MD
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Kimberly Salkey, MD
    • Washington
      • Mill Creek, Washington, United States, 98012
      • Spokane, Washington, United States, 99202
        • Terminated
        • Spokane Dermatology Clinic
    • West Virginia
      • Morgantown, West Virginia, United States, 26542
        • Terminated
        • Dermatology Center for Skin Health
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
          • Alexandria Cook
          • Phone Number: 414-266-6165
        • Principal Investigator:
          • Heidi Zafra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults and children (all ages) with with Atopic Dermatitis or other IMISC been prescribed any dermatologic treatment.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
25 Years
Evaluate Patient Outcomes in Clinical Practice
Time Frame: 25 Years
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
25 Years
Evaluate Adverse Events of IMISC and treatment in Clinical Practice
Time Frame: 25 Years
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
Time Frame: 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.
25 Years
Evaluate Patient Reported Outcome (PRO) measures
Time Frame: 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.
25 Years
Evaluate outcomes related to Patient Support Programs (PSPs)
Time Frame: 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.
25 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Target PharmaSolutions, Inc.

Investigators

  • Study Director: Laura Dalfonso, Target RWE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2018

Primary Completion (Estimated)

December 1, 2050

Study Completion (Estimated)

December 1, 2050

Study Registration Dates

First Submitted

September 4, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET-DERM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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