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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 22, 2019
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

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.

Condition or disease
Atopic Dermatitis Alopecia Hidradenitis Suppurativa Vitiligo Psoriasis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : October 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Characterize IMISC Treatment Regimens in Clinical Practice [ Time Frame: 5 Years ]
    Enable characterization of IMISC disease activity and comorbid medical conditions over time.

  2. Evaluate Patient Outcomes in Clinical Practice [ Time Frame: 5 Years ]
    Enable characterization of IMISC disease activity and comorbid medical conditions over time.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults and children (all ages) with with Atopic Dermatitis or other IMISC been prescribed any dermatologic treatment.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661866


Contacts
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Contact: Laura Dalfonso 9842340268 ldalfonso@targetpharmasolutions.com
Contact: Laura Malahias 9842340268 ext 209 lmalahias@targetpharmasolutions.com

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Sponsors and Collaborators
Target PharmaSolutions, Inc.
Investigators
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Study Director: Laura Dalfonso TARGET PharmaSolutions

Additional Information:

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Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT03661866     History of Changes
Other Study ID Numbers: TARGET-DERM
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Target PharmaSolutions, Inc.:
Atopic Dermatitis
IMISC
Registry
Observational
Immune-mediated Inflammatory Skin Conditions
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Dermatitis, Atopic
Psoriasis
Dermatitis
Eczema
Alopecia
Vitiligo
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical
Hypopigmentation
Pigmentation Disorders
Sweat Gland Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration