Stress Response Pathways in Vitiligo

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

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Punch Biopsy at a Lesional Site; Procedure: Punch Biopsy at a Non- Lesional site

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
T-test measures of expression levels in response to Vitiligo triggers	1 Year

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Prashiela Manga, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 13, 2016

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: 15-00445

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No