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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02797574
Other study ID # 15-00445
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date September 22, 2021

Study information

Verified date November 2021
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date September 22, 2021
Est. primary completion date September 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Punch Biopsy at a Lesional Site

Punch Biopsy at a Non- Lesional site


Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary T-test measures of expression levels of target proteins in patients versus controls (p < 0.05) 1 Year
Secondary T-test measures of expression levels in response to Vitiligo triggers 1 Year
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