Vitiligo
Conditions
Brief summary
The design is a prospective, observational (non-interventional) registry for adolescent and adult subjects with NSV under the care of a dermatology provider.
Detailed description
The objective of the registry is to create a cohort of adult and adolescent nonsegmental vitiligo (NSV) subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for NSV. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of NSV, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs.
Interventions
None listed
Sponsors
CorEvitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Individuals are eligible for enrollment if they meet all of the following criteria: * Have a dermatologist- or qualified dermatology practitioner-confirmed diagnosis of nonsegmental vitiligo (NSV). * Is at least 12 years of age or older at the time of enrollment. * Is willing and able to provide informed consent or assent, with parent/legal guardian consent as applicable. * Adult participants are willing and able to provide required personal information • Full legal name, sex, date of birth, and home ZIP/postal code * Meet the criteria for one of the following enrollment cohorts at the time of enrollment: Cohort 1: Eligible Medication Initiators - Individuals initiating a prescribed eligible NSV medication at the time of enrollment. Cohort 2: Not Initiating Eligible Medication - Individuals not currently receiving NSV medication at the time of enrollment, Individuals receiving eligible NSV medication prior to enrollment.
Exclusion criteria
An individual who meets any of the following criteria will be excluded from participation in the registry: \- Is participating or planning to participate in a blinded clinical trial for a vitiligo therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitiligo Epidemiology and presentation | Every 6 months for 10 years] | The major clinical outcome include an assessment of the epidemiology of Vitiligo. This will be determined using PROs and ClinROs which will be included as part of the case report forms. |
Countries
United States
Contacts
CONTACTVitiligo Registry Study Team
Outcome results
None listed