Clinical trial NCT02797574: Stress Response Pathways in Vitiligo
Official title: Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)
timeFrame: 1 Year
Secondary outcomes:
measure: T-test measures of expression levels in response to Vitiligo triggers
timeFrame: 1 Year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Prashiela Manga, MD
role: PRINCIPAL_INVESTIGATOR
References: