Atopic Dermatitis (TARGET-DERM Study)

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.

Condition or Disease

Atopic Dermatitis

Alopecia Areata

Hidradenitis Suppurativa

Vitiligo

Psoriasis

Chronic Spontaneous Urticaria

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]
Estimated Enrollment: 15000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 50 Years
Official Title: A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
Actual Study Start Date: December 21, 2018
Estimated Primary Completion Date: December 2050
Estimated Study Completion Date: December 2050

Outcome Measures

Primary Outcome Measures

  1. Characterize IMISC Treatment Regimens in Clinical Practice [ Time Frame: 25 Years ]
    Enable characterization of IMISC disease activity and comorbid medical conditions over time.
  2. Evaluate Patient Outcomes in Clinical Practice [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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

Ages Eligible for Study: Child, Adult, Older Adult
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method:   Non-Probability Sample

Inclusion Criteria

  • Adults and children (all ages) with Atopic Dermatitis or other Immune-mediated Inflammatory Skin Conditions been prescribed any dermatologic treatment.
  • Participant has plans for future visits at the site for continued management of IMISC.

Exclusion Criteria

  • Inability to provide written informed consent/assent.
  • ¬†| Clinical Trials | U.S. Dermatology PartnersSubjects 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)
ADDITIONAL DETAILS