Stress Response Pathways in Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797574
• Other study ID #: 15-00445
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Vitiligo

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