Vitiligo Clinical Trial
Official title:
Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
Verified date | November 2021 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 22, 2021 |
Est. primary completion date | September 22, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | T-test measures of expression levels of target proteins in patients versus controls (p < 0.05) | 1 Year | ||
Secondary | T-test measures of expression levels in response to Vitiligo triggers | 1 Year |
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