A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

NCT03661866 | Active Not Recruiting

• 1 other identifier: TARGET-DERM
• Study Type: observational
• Target: 15,000
• Locations: 4 countries
• Sites: 62

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.

Conditions

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

Keywords

Atopic Dermatitis; IMISC; Registry; Observational; Immune-mediated Inflammatory Skin Conditions

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Evaluate the relationship between IMISC and comorbid medical conditions

  25 Years

• Evaluate Patient Reported Outcome (PRO) measures

  25 Years

• Evaluate outcomes related to Patient Support Programs (PSPs)

  25 Years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. Adults and children (all ages) with Atopic Dermatitis or other Immune-mediated Inflammatory Skin Conditions been prescribed any dermatologic treatment.
• \. Participant has plans for future visits at the site for continued management of IMISC.

You may not qualify if:

• \. Inability to provide written informed consent/assent.
• \. 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).

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Study Sites (62)

Clear Dermatology & Aesthetics Center/Investigative MD

Scottsdale, Arizona, 85255, United States

Location

Johnson Dermatology

Fort Smith, Arkansas, 72916, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Arkansas Dermatology

Little Rock, Arkansas, 72223, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Center for Dermatology Cosmetic and Laser Surgery

Fremont, California, 94538, United States

Location

University of California

Irvine, California, 92697, United States

Location

University of California - San Diego/Rady Children's Hospital

San Diego, California, 92123, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Feinstein Dermatology and Cosmetic Surgery

Hollywood, Florida, 33021, United States

Location

Academic Alliance in Dermatology

Tampa, Florida, 33614, United States

Location

Integrated Dermatology of West Palm Beach

West Palm Beach, Florida, 33406, United States

Location

Lurie Children's Hospital/Northwestern University

Chicago, Illinois, 60611, United States

Location

Dawes Fretzin Dermatology/ Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46520, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Family Allergy and Asthma Research Institute

Louisville, Kentucky, 40215, United States

Location

DermAssociates, LCC

Rockville, Maryland, 20850, United States

Location

Integrated Dermatology of Massachusetts

Quincy, Massachusetts, 02169, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Carl Thornblade, MD, PLLC

Missoula, Montana, 59808, United States

Location

South Lincoln Dermatology Clinic

Lincoln, Nebraska, 68502, United States

Location

Advanced Dermatology of the Midlands

Omaha, Nebraska, 68144, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Windsor Dermatology

East Windsor, New Jersey, 08520, United States

Location

Linda Susan Marcus

Wyckoff, New Jersey, 07481, United States

Location

Centurion Dermatology

Brooklyn, New York, 11219, United States

Location

The University of Buffalo

Buffalo, New York, 14203, United States

Location

Empire Dermatology

East Syracuse, New York, 13057, United States

Location

Forest Hills Dermatology Group

Forest Hills, New York, 11375, United States

Location

Greenwich Village Dermatology

New York, New York, 10012, United States

Location

Ichan School of Medicine

New York, New York, 10029, United States

Location

Advanced Allergy & Asthma, PLLC

Rockville Centre, New York, 11570, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Allergy Partners of Western North Carolina

Asheville, North Carolina, 28801, United States

Location

UNC Dermatology

Chapel Hill, North Carolina, 27516, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Ohio State University

Columbus, Ohio, 43215, United States

Location

Allergy, Asthma & Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Allergy and Clinical Immunology

Pittsburgh, Pennsylvania, 15241, United States

Location

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

El Paso Dermatology Center

El Paso, Texas, 79902, United States

Location

North Texas Center for Clinical Research

Frisco, Texas, 75034, United States

Location

Asthma and Allergy Center

Lewisville, Texas, 75067, United States

Location

Center for Clinical Studies

Webster, Texas, 77598, United States

Location

Allergy Associates of Utah

Murray, Utah, 84107, United States

Location

University of Utah MidValley Dermatology

Murray, Utah, 84107, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

North Sound Dermatology

Mill Creek, Washington, 98012, United States

Location

Spokane Dermatology Clinic

Spokane, Washington, 99202, United States

Location

Dermatology Center for Skin Health

Morgantown, West Virginia, 26542, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Skin Centre for Dermatology

Peterborough, Ontario, Canada

Location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4B 1L1, Canada

Location

Innovaderm Research, Inc.

Montreal, Quebec, Canada

Location

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, Canada

Location

Dr. Bernhard Korge

Düren, North Rhine-Westphalia, 52349, Germany

Location

UKSH- Institut für Entzündungsmedizin

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Related Publications (1)

• Abuabara K, Silverberg JI, Simpson EL, Paller AS, Eichenfield LF, Bissonnette R, Krueger J, Harris JE, Dalfonso L, Watkins SE, Crawford JM, Thaci D, Guttman-Yassky E. International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale. BMJ Open. 2020 Nov 27;10(11):e039928. doi: 10.1136/bmjopen-2020-039928.

  PMID: 33247014 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients enrolled in TARGET-DERM may be invited to participate in the Biorepository Bank (BSB). Blood, buccal and tape strip samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study identification (ID) number and the date the sample was obtained.

MeSH Terms

Conditions

Dermatitis, Atopic; Alopecia Areata; Hidradenitis Suppurativa; Vitiligo; Psoriasis; Chronic Urticaria

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases; Hypopigmentation; Pigmentation Disorders; Skin Diseases, Papulosquamous; Urticaria; Skin Diseases, Vascular; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Dalfonso

  Target RWE

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 50 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: December 21, 2018
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (54); CA (4); DE (2); ES (2)