Stress Response Pathways in Vitiligo

NCT ID: NCT02797574

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2021-09-22

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.

Conditions

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Vitiligo

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitiligo Diagnosed Group

Clinically diagnosed with non-segmental vitiligo

Group Type ACTIVE_COMPARATOR

Punch Biopsy at a Lesional Site

Intervention Type PROCEDURE

Punch Biopsy at a Non- Lesional site

Intervention Type PROCEDURE

Healthy Control Group

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

Group Type ACTIVE_COMPARATOR

Punch Biopsy at a Non- Lesional site

Intervention Type PROCEDURE

Interventions

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Punch Biopsy at a Lesional Site

Intervention Type PROCEDURE

Punch Biopsy at a Non- Lesional site

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prashiela Manga, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-00445

Identifier Type: -

Identifier Source: org_study_id