A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC

Psoriasis Clinical Trial

— TARGET-DERM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03661866
• Other study ID #: TARGET-DERM
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Atopic Dermatitis
• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Hidradenitis
• Hidradenitis Suppurativa
• Psoriasis
• Urticaria
• Vitiligo

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