An Observational Study of Patients With Dermatologic Disease (TARGET-DERM+)
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Lynda Lee Burch
- Phone Number: 9842340268
- Email: lburch@pedestalhealth.com
Study Contact Backup
- Name: Laura Dalfonso
- Phone Number: 9842340268
- Email: ldalfonso@pedestalhealth.com
Study Locations
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New York
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New York, New York, United States, 10012
- Greenwich Village Dermatology
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Contact:
- Jasmina Jeter
- Phone Number: 212-385-3700
- Email: jjeter@thedermspecs.com
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Principal Investigator:
- Andrew Peranteau
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult or pediatric participants managed for DD invited to participate OR a provider who treats patients with these conditions. Informed consent is required for all Engaged Cohort participants.
- Adult or pediatric participants at the time of enrollment with a diagnosis of DD by ICD code or other relevant healthcare code as part of the EHR interface.
Exclusion Criteria:
- Participant withdrew consent; Failure to complete activities as required per the cohort clarification letter.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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Disease Cohort
Adult patients and patients under the age of majority with a diagnosis of DD by ICD or other relevant healthcare code in the EHR interface.
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Engaged Cohort
Adult patients and patients under the age of majority diagnosed and managed for DD invited to participate OR HCPs who treat patients with these conditions.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To assess safety and effectiveness of DD treatments and treatments for complications of any dermatologic disease
Time Frame: 15 years
|
The study will evaluate the characteristics of patients receiving various treatments, effectiveness of treatment, and medical events that develop while receiving treatment for DD
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15 years
|
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To characterize the natural history of disease in patients with dermatologic disease from various etiologies
Time Frame: 15 years
|
A detailed analysis of available demographics (age, race, sex, country of birth, insurance status), medications, co-morbidities, and medical history from sites across the US will inform the profile for this patient population.
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15 years
|
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To establish learning health networks focused on quality of care for patients
Time Frame: 15 years
|
Identify deficiencies and best practices in care of patients with DD. • Evaluate outcomes from targeted learning content in the management of patients with DD. |
15 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate provider management practices in the treatment of patients with DD
Time Frame: 15 years
|
Health care provider type, clinic setting, reason for initiating/not initiating/adjusting dosing of treatments, reason for discontinuing/switching treatments, and monitoring outcomes on and off treatment, will be captured as available in the provided EHR and/or through linked data.
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15 years
|
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To evaluate longitudinal and patient reported outcomes in DD
Time Frame: 15 years
|
Longitudinal clinical outcomes and disease progression will be assessed.
Self-reported patient health measures collect information directly from patients to measure physical, mental, and social health.
|
15 years
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Laura Dalfonso, Pedestal Health
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Genetic Diseases, Inborn
- Immune System Diseases
- Infections
- Hypersensitivity, Immediate
- Hypersensitivity
- Alopecia
- Hypotrichosis
- Hair Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Sweat Gland Diseases
- Skin Diseases, Bacterial
- Skin Diseases, Infectious
- Suppuration
- Hypopigmentation
- Pigmentation Disorders
- Skin Diseases, Genetic
- Skin Diseases, Eczematous
- Dermatitis
- Hidradenitis
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Skin and Connective Tissue Diseases
- Alopecia Areata
- Hidradenitis Suppurativa
- Vitiligo
- Dermatitis, Atopic
- Skin Diseases
Other Study ID Numbers
Other Study ID Numbers
- TARGET-DERM+
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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