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.
Brief Title
A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC
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.
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
9842340268
Central Contact Email
ldalfonso@targetrwe.com
Central Contact Role
Contact
Central Contact Phone
9842340268
Central Contact Email
lburch@targetrwe.com
Completion Date
Completion Date Type
Estimated
Conditions
Atopic Dermatitis
Alopecia Areata
Hidradenitis Suppurativa
Vitiligo
Psoriasis
Chronic Spontaneous Urticaria
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).
* 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).
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Atopic Dermatitis
IMISC
Registry
Observational
Immune-mediated Inflammatory Skin Conditions
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT03661866
Org Class
Industry
Org Full Name
Target PharmaSolutions, Inc.
Org Study Id
TARGET-DERM
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions
Primary Outcomes
Outcome Description
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Outcome Measure
Characterize IMISC Treatment Regimens in Clinical Practice
Outcome Time Frame
25 Years
Outcome Description
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Outcome Measure
Evaluate Patient Outcomes in Clinical Practice
Outcome Time Frame
25 Years
Outcome Description
Enable characterization of IMISC disease activity and comorbid medical conditions over time.
Outcome Measure
Evaluate Adverse Events of IMISC and treatment in Clinical Practice
Outcome Time Frame
25 Years
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
25 Years
Outcome Measure
Evaluate the relationship between IMISC and comorbid medical conditions
Outcome Description
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.
Outcome Time Frame
25 Years
Outcome Measure
Evaluate Patient Reported Outcome (PRO) measures
Outcome Description
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.
Outcome Time Frame
25 Years
Outcome Measure
Evaluate outcomes related to Patient Support Programs (PSPs)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Adults and children (all ages) with with Atopic Dermatitis or other IMISC been prescribed any dermatologic treatment.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Holly Kanavy
Investigator Email
HKanavy@montefiore.org
Investigator Phone
866-633-8255 / 718-230-2997 / 510-996-0741