Stress Response Pathways in Vitiligo

NYU Langone Health

Status: Completed

Conditions: Vitiligo

Treatments: Procedure: Punch Biopsy at a Lesional Site; Procedure: Punch Biopsy at a Non- Lesional site

Study type: Interventional

Funder types: Other

Identifiers

NCT02797574

15-00445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Vitiligo Diagnosed Group

Active Comparator group

Description:

Clinically diagnosed with non-segmental vitiligo

Treatment:

Procedure: Punch Biopsy at a Lesional Site

Procedure: Punch Biopsy at a Non- Lesional site

Healthy Control Group

Active Comparator group

Description:

20 normally pigmented control subjects who are between the ages of 18 and 50

Treatment:

Procedure: Punch Biopsy at a Non- Lesional site