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

Sponsor
Target PharmaSolutions, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03661866
Collaborator
(none)
15,000
57
383.3
263.2
0.7

Study Details

Study Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
15000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
Actual Study Start Date :
Dec 21, 2018
Anticipated Primary Completion Date :
Dec 1, 2050
Anticipated Study Completion Date :
Dec 1, 2050

Outcome Measures

Primary Outcome Measures

  1. Characterize IMISC Treatment Regimens in Clinical Practice [25 Years]

    Enable characterization of IMISC disease activity and comorbid medical conditions over time.

  2. Evaluate Patient Outcomes in Clinical Practice [25 Years]

    Enable characterization of IMISC disease activity and comorbid medical conditions over time.

  3. Evaluate Adverse Events of IMISC and treatment in Clinical Practice [25 Years]

    Enable characterization of IMISC disease activity and comorbid medical conditions over time.

Secondary Outcome Measures

  1. Evaluate the relationship between IMISC and comorbid medical conditions [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.

  2. Evaluate Patient Reported Outcome (PRO) measures [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.

  3. Evaluate outcomes related to Patient Support Programs (PSPs) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Adults and children (all ages) with Atopic Dermatitis or other Immune-mediated Inflammatory Skin Conditions been prescribed any dermatologic treatment.
    1. Participant has plans for future visits at the site for continued management of IMISC.
Exclusion Criteria:
    1. Inability to provide written informed consent/assent.
    1. 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clear Dermatology & Aesthetics Center/Investigative MD Scottsdale Arizona United States 85255
2 Johnson Dermatology Fort Smith Arkansas United States 72916
3 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
4 Arkansas Dermatology Little Rock Arkansas United States 72223
5 First OC Dermatology Fountain Valley California United States 92708
6 Center for Dermatology Cosmetic and Laser Surgery Fremont California United States 94538
7 University of California Irvine California United States 92697
8 University of California - San Diego/Rady Children's Hospital San Diego California United States 92123
9 University of Colorado - Anschutz Medical Campus Aurora Colorado United States 80045
10 George Washington University Washington District of Columbia United States 20037
11 Feinstein Dermatology and Cosmetic Surgery Hollywood Florida United States 33021
12 Academic Alliance in Dermatology Tampa Florida United States 33614
13 Integrated Dermatology of West Palm Beach West Palm Beach Florida United States 33406
14 Lurie Children's Hospital/Northwestern University Chicago Illinois United States 60611
15 Dawes Fretzin Dermatology/ Dawes Fretzin Clinical Research Group Indianapolis Indiana United States 46520
16 The University of Kansas Medical Center Kansas City Kansas United States 66160
17 Family Allergy and Asthma Research Institute Louisville Kentucky United States 40215
18 DermAssociates, LCC Rockville Maryland United States 20850
19 Integrated Dermatology of Massachusetts Quincy Massachusetts United States 02169
20 University of Massachusetts Medical School Worcester Massachusetts United States 01605
21 University of Minnesota Minneapolis Minnesota United States 55455
22 Mayo Clinic Rochester Minnesota United States 55905
23 Carl Thornblade, MD, PLLC Missoula Montana United States 59808
24 South Lincoln Dermatology Clinic Lincoln Nebraska United States 68502
25 Advanced Dermatology of the Midlands Omaha Nebraska United States 68144
26 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03756
27 Windsor Dermatology East Windsor New Jersey United States 08520
28 Linda Susan Marcus Wyckoff New Jersey United States 07481
29 Montefiore Medical Center Bronx New York United States 10467
30 The University of Buffalo Buffalo New York United States 14203
31 Empire Dermatology East Syracuse New York United States 13057
32 Forest Hills Dermatology Group Forest Hills New York United States 11375
33 Greenwich Village Dermatology New York New York United States 10012
34 Ichan School of Medicine New York New York United States 10029
35 Advanced Allergy & Asthma, PLLC Rockville Centre New York United States 11570
36 Allergy Partners of Western North Carolina Asheville North Carolina United States 28801
37 UNC Dermatology Chapel Hill North Carolina United States 27516
38 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
39 Ohio State University Columbus Ohio United States 43215
40 Allergy, Asthma & Clinical Research Center Oklahoma City Oklahoma United States 73120
41 Oregon Health and Science University Portland Oregon United States 97239
42 Allergy and Clinical Immunology Pittsburgh Pennsylvania United States 15241
43 The Medical University of South Carolina Charleston South Carolina United States 29425
44 El Paso Dermatology Center El Paso Texas United States 79902
45 Asthma and Allergy Center Lewisville Texas United States 75067
46 Center for Clinical Studies Webster Texas United States 77598
47 Allergy Associates of Utah Murray Utah United States 84107
48 University of Utah MidValley Dermatology Murray Utah United States 84107
49 Virginia Commonwealth University Richmond Virginia United States 23219
50 Spokane Dermatology Clinic Spokane Washington United States 99202
51 Dermatology Center for Skin Health Morgantown West Virginia United States 26542
52 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
53 Skin Centre for Dermatology Peterborough Ontario Canada
54 York Dermatology Clinic and Research Centre Richmond Hill Ontario Canada L4C 9M7
55 Innovaderm Research, Inc. Montréal Quebec Canada
56 Dermatologische Gemeinschaftspraxis Mahlow Mahlow Bradenburg Germany 15831
57 UKSH- Institut für Entzündungsmedizin Lübeck Schleswig-Holstein Germany 23538

Sponsors and Collaborators

  • Target PharmaSolutions, Inc.

Investigators

  • Study Director: Laura Dalfonso, TARGET PharmaSolutions

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier:
NCT03661866
Other Study ID Numbers:
  • TARGET-DERM
First Posted:
Sep 7, 2018
Last Update Posted:
Aug 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Target PharmaSolutions, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022