Stress Response Pathways in Vitiligo

Not Applicable

Completed

• Conditions: Vitiligo
• Interventions: Procedure: Punch Biopsy at a Lesional Site; Procedure: Punch Biopsy at a Non- Lesional site

• Registration Number: NCT02797574
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-13
• Primary Completion: 2021-09-22
• Study Completion: 2021-09-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitiligo Diagnosed Group	Punch Biopsy at a Non- Lesional site	Clinically diagnosed with non-segmental vitiligo
Vitiligo Diagnosed Group	Punch Biopsy at a Lesional Site	Clinically diagnosed with non-segmental vitiligo
Healthy Control Group	Punch Biopsy at a Non- Lesional site	20 normally pigmented control subjects who are between the ages of 18 and 50

Primary Outcome Measures

Name	Time	Method
T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)	1 Year

Secondary Outcome Measures

Name	Time	Method
T-test measures of expression levels in response to Vitiligo triggers	1 Year

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States