Back to resultsStress Response Pathways in Vitiligo
Primary Purpose
Vitiligo
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Punch Biopsy at a Lesional Site
Punch Biopsy at a Non- Lesional site
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vitiligo Diagnosed Group
Healthy Control Group
Arm Description
Clinically diagnosed with non-segmental vitiligo
20 normally pigmented control subjects who are between the ages of 18 and 50
Outcomes
Primary Outcome Measures
T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)
Secondary Outcome Measures
T-test measures of expression levels in response to Vitiligo triggers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02797574
Brief Title
Stress Response Pathways in Vitiligo
Official Title
Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitiligo Diagnosed Group
Arm Type
Active Comparator
Arm Description
Clinically diagnosed with non-segmental vitiligo
Arm Title
Healthy Control Group
Arm Type
Active Comparator
Arm Description
20 normally pigmented control subjects who are between the ages of 18 and 50
Intervention Type
Procedure
Intervention Name(s)
Punch Biopsy at a Lesional Site
Intervention Type
Procedure
Intervention Name(s)
Punch Biopsy at a Non- Lesional site
Primary Outcome Measure Information:
Title
T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
T-test measures of expression levels in response to Vitiligo triggers
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prashiela Manga, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stress Response Pathways in Vitiligo
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