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Stress Response Pathways in Vitiligo

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ClinicalTrials.gov Identifier: NCT02797574
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: Punch Biopsy at a Lesional Site Procedure: Punch Biopsy at a Non- Lesional site Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
Study Start Date : October 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

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



Primary Outcome Measures :
  1. T-test measures of expression levels of target proteins in patients versus controls (p < 0.05) [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. T-test measures of expression levels in response to Vitiligo triggers [ Time Frame: 1 Year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797574


Contacts
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Contact: Megan McLachlan mclacm01@nyumc.org
Contact: Brandon Cohen Brandon.Cohen@med.nyu.edu

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Megan McLachlan       mclacm01@nyumc.org   
Contact: Brandon Cohen       Brandon.Cohen@med.nyu.edu   
Principal Investigator: Prashiela Manga, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Prashiela Manga, MD New York University Medical School

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02797574     History of Changes
Other Study ID Numbers: 15-00445
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases