Vitiligo
Conditions
Brief summary
The purpose of this study is to investigate stress response pathways in tissues and melanocytes from patients with vitiligo. Investigators are collecting evidence of UPR and stress response activation in tissues and melanocytes from patients with vitiligo. Individuals with vitiligo will have punch biopsies to study stress response UPR activation and NF-κB signaling to test our hypothesis. In order to characterize differences between disease and normal states, a second arm of control individuals (Arm 2) will be recruited.
Detailed description
Identifying a role for NF-κB signaling in vitiligo may improve therapies for this disfiguring disorder. Current treatments vary in effectiveness and may not always be long lasting cases. The NF-κB pathway and IL-6 itself are the target of several FDA approved drugs, thus opening new therapeutic avenues.
Interventions
PROCEDUREPunch Biopsy at a Lesional Site
PROCEDUREPunch Biopsy at a Non- Lesional site
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* To be eligible for participation, subjects must meet all of the following criteria: * Must have a clinical exam consistent with and diagnosis of non-segmental vitiligo * Must be normally pigmented * No clinical presentation of vitiligo
Exclusion criteria
* Outside of the specified age range * No clinical diagnosis of vitiligo * Use of systemic therapies, including but not limited to methotrexate, etretinate, or cyclosporine, calcineurin inhibitors and/ or vitamin D analogs within 4 weeks of enrollment * Use of topical steroids or topical immunodilators at biopsy site within 4 weeks of enrollment * History of keloids or hypertrophic scars * Patients with pacemakers or defibrillators or heart valves * Patients on Plavix, Warfarin or similar anticoagulation medicine * Pregnant females * Lactating women * Allergies or sensitivity to lidocaine or epinephrine * Outside of the specified age range * Abnormally pigmented at potential biopsy sites (non-vitiligo) * Clinical presentation of vitiligo * Use of systemic therapies, including but not limited to methotrexate, etretinate, or cyclosporine, calcineuron inhibitors and/ or vitamin D analogs within 4 weeks of enrollment * Use of topical steroids or topical immunodilators at biopsy site within 4 weeks of enrollment * History of keloids or hypertrophic scars
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T-test measures of expression levels of target proteins in patients versus controls (p < 0.05) | 1 Year |
Secondary
| Measure | Time frame |
|---|---|
| T-test measures of expression levels in response to Vitiligo triggers | 1 Year |
Countries
United States
Outcome results
None listed