PPDTM CorEvitasTM Vitiligo Drug Safety and Effectiveness Registry for Adults & Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vitiligo. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Vitiligo Epidemiology and presentation [Time frame: Every 6 months for 10 years]]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- CorEvitas, LLC — Waltham
Identifiers
NCT: NCT07659418 · CorEvitas-VIT-520