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Completed

NCT Number: NCT02797574

Stress Response Pathways in Vitiligo

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Punch Biopsy at a Lesional Site

Procedure

Punch Biopsy at a Non- Lesional site

Procedure

Primary outcomes

  1. T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)

    Time frame: 1 Year

Secondary outcomes

  1. T-test measures of expression levels in response to Vitiligo triggers

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2016
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.