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A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for IMISC (TARGET-DERM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03661866
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Tracking Information
First Submitted Date September 4, 2018
First Posted Date September 7, 2018
Last Update Posted Date October 23, 2020
Actual Study Start Date December 21, 2018
Estimated Primary Completion Date October 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2018)
  • Characterize IMISC Treatment Regimens in Clinical Practice [ Time Frame: 5 Years ]
    Enable characterization of IMISC disease activity and comorbid medical conditions over time.
  • Evaluate Patient Outcomes in Clinical Practice [ Time Frame: 5 Years ]
    Enable characterization of IMISC disease activity and comorbid medical conditions over time.
  • Evaluate Adverse Events of IMISC and treatment in Clinical Practice [ Time Frame: 5 Years ]
    Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 4, 2018)
  • Evaluate the relationship between IMISC and comorbid medical conditions [ Time Frame: 5 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.
  • Evaluate Patient Reported Outcome (PRO) measures [ Time Frame: 5 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.
  • Evaluate outcomes related to Patient Support Programs (PSPs) [ Time Frame: 5 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for IMISC
Official Title A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
Brief Summary TARGET-DERM is a 5-year, 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 Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Adults and children (all ages) with with Atopic Dermatitis or other IMISC been prescribed any dermatologic treatment.
Condition
  • Atopic Dermatitis
  • Alopecia
  • Hidradenitis Suppurativa
  • Vitiligo
  • Psoriasis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 4, 2018)
15000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2026
Estimated Primary Completion Date October 31, 2026   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Laura Dalfonso 9842340268 ldalfonso@targetpharmasolutions.com
Contact: Laura Malahias 9842340268 ext 209 lmalahias@targetpharmasolutions.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03661866
Other Study ID Numbers TARGET-DERM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Target PharmaSolutions, Inc.
Study Sponsor Target PharmaSolutions, Inc.
Collaborators Not Provided
Investigators
Study Director: Laura Dalfonso TARGET PharmaSolutions
PRS Account Target PharmaSolutions, Inc.
Verification Date October 2020