Stress Response Pathways in Vitiligo

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms

Conditions
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Vitiligo

Intervention / Treatment
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* Procedure: Punch Biopsy at a Lesional Site
* Procedure: Punch Biopsy at a Non- Lesional site


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitiligo Diagnosed Group<br>Clinically diagnosed with non-segmental vitiligo | Procedure: Punch Biopsy at a Lesional Site<br> <br> Procedure: Punch Biopsy at a Non- Lesional site<br> <br> |
| Active Comparator: Healthy Control Group<br>20 normally pigmented control subjects who are between the ages of 18 and 50 | Procedure: Punch Biopsy at a Non- Lesional site<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-test measures of expression levels of target proteins in patients versus controls (p < 0.05) |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-test measures of expression levels in response to Vitiligo triggers |  | 1 Year |