Clinical trial NCT03661866: A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC
Official title: A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Alopecia Areata
Hidradenitis Suppurativa
Vitiligo
Psoriasis
Chronic Spontaneous Urticaria
Keywords: Atopic Dermatitis
IMISC
Registry
Observational
Immune-mediated Inflammatory Skin Conditions
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children (all ages) with with Atopic Dermatitis or other IMISC been prescribed any dermatologic treatment.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Characterize IMISC Treatment Regimens in Clinical Practice
timeFrame: 25 Years
measure: Evaluate Patient Outcomes in Clinical Practice
timeFrame: 25 Years
measure: Evaluate Adverse Events of IMISC and treatment in Clinical Practice
timeFrame: 25 Years
Secondary outcomes:
measure: Evaluate the relationship between IMISC and comorbid medical conditions
timeFrame: 25 Years
measure: Evaluate Patient Reported Outcome (PRO) measures
timeFrame: 25 Years
measure: Evaluate outcomes related to Patient Support Programs (PSPs)
timeFrame: 25 Years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center/Investigative MD
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Fremont
country: United States
facility: Center for Dermatology Cosmetic and Laser Surgery
state: California
city: Irvine
country: United States
facility: University of California
state: California
city: San Diego
country: United States
facility: University of California - San Diego/Rady Children's Hospital
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Hollywood
country: United States
facility: Feinstein Dermatology and Cosmetic Surgery
state: Florida
city: Tampa
country: United States
facility: Academic Alliance in Dermatology
state: Florida
city: West Palm Beach
country: United States
facility: Integrated Dermatology of West Palm Beach
state: Florida
city: Chicago
country: United States
facility: Lurie Children's Hospital/Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology/ Dawes Fretzin Clinical Research Group
state: Indiana
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Family Allergy and Asthma Research Institute
state: Kentucky
city: Rockville
country: United States
facility: DermAssociates, LCC
state: Maryland
city: Quincy
country: United States
facility: Integrated Dermatology of Massachusetts
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Missoula
country: United States
facility: Carl Thornblade, MD, PLLC
state: Montana
city: Lincoln
country: United States
facility: South Lincoln Dermatology Clinic
state: Nebraska
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: East Windsor
country: United States
facility: Windsor Dermatology
state: New Jersey
city: Wyckoff
country: United States
facility: Linda Susan Marcus
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Centurion Dermatology
state: New York
city: Buffalo
country: United States
facility: The University of Buffalo
state: New York
city: East Syracuse
country: United States
facility: Empire Dermatology
state: New York
city: Forest Hills
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Greenwich Village Dermatology
state: New York
city: New York
country: United States
facility: Ichan School of Medicine
state: New York
city: Rockville Centre
country: United States
facility: Advanced Allergy & Asthma, PLLC
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Dermatology
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology
state: Pennsylvania
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
city: El Paso
country: United States
facility: El Paso Dermatology Center
state: Texas
city: Frisco
country: United States
facility: North Texas Center for Clinical Research
state: Texas
city: Lewisville
country: United States
facility: Asthma and Allergy Center
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Murray
country: United States
facility: Allergy Associates of Utah
state: Utah
city: Murray
country: United States
facility: University of Utah MidValley Dermatology
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Mill Creek
country: United States
facility: North Sound Dermatology
state: Washington
city: Spokane
country: United States
facility: Spokane Dermatology Clinic
state: Washington
city: Morgantown
country: United States
facility: Dermatology Center for Skin Health
state: West Virginia
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Montréal
country: Canada
facility: Innovaderm Research, Inc.
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Dermatology Centre
state: Saskatchewan
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow
state: Bradenburg
city: Düren
country: Germany
facility: Dr. Bernhard Korge
state: NRW
city: Lübeck
country: Germany
facility: UKSH- Institut für Entzündungsmedizin
state: Schleswig-Holstein
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
Study officials:
affiliation: Target RWE
name: Laura Dalfonso
role: STUDY_DIRECTOR
References:
citation: 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.