Stress Response Pathways in Vitiligo

NCT02797574 | Completed

• 1 other identifier: 15-00445
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

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

  1 Year

Secondary Outcomes (1)

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

  1 Year

Study Arms (2)

Vitiligo Diagnosed Group

ACTIVE COMPARATOR

Clinically diagnosed with non-segmental vitiligo

Procedure: Punch Biopsy at a Lesional Site; Procedure: Punch Biopsy at a Non- Lesional site

Healthy Control Group

ACTIVE COMPARATOR

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

Procedure: Punch Biopsy at a Non- Lesional site

Interventions

Punch Biopsy at a Lesional Site PROCEDURE

Vitiligo Diagnosed Group

Punch Biopsy at a Non- Lesional site PROCEDURE

Healthy Control Group; Vitiligo Diagnosed Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Prashiela Manga, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: June 13, 2016
• Study Start: October 1, 2015
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)