Stress Response Pathways in Vitiligo | NCT02797574

Studies
Stress Response Pathways in Vitiligo

NCT02797574

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Nov 16, 2021Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Vitiligo

Interventions

Punch Biopsy at a Lesional Site
Punch Biopsy at a Non- Lesional site

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015Actual

Primary Completion Date

Sep 22, 2021Actual

Completion Date

Sep 22, 2021Actual

First Submitted Date

Feb 4, 2016

First Submission Date that Met QC Criteria

Jun 8, 2016

First Posted Date

Jun 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2021

Last Update Posted Date

Nov 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Punch Biopsy at a Lesional Site	Procedure		Vitiligo Diagnosed Group
Punch Biopsy at a Non- Lesional site

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

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases