Stress Response Pathways in Vitiligo

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02797574
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 71.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Procedure: Punch Biopsy at a Lesional Site; Procedure: Punch Biopsy at a Non- Lesional site	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Sep 22, 2021
• Actual Study Completion Date: Sep 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitiligo Diagnosed Group Clinically diagnosed with non-segmental vitiligo	Procedure: Punch Biopsy at a Lesional Site; Procedure: Punch Biopsy at a Non- Lesional site
Active Comparator: Healthy Control Group 20 normally pigmented control subjects who are between the ages of 18 and 50	Procedure: Punch Biopsy at a Non- Lesional site

Outcome Measures

Primary Outcome Measures

1. T-test measures of expression levels of target proteins in patients versus controls (p < 0.05) [1 Year]

Secondary Outcome Measures

1. T-test measures of expression levels in response to Vitiligo triggers [1 Year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Prashiela Manga, MD, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02797574
• Other Study ID Numbers: 15-00445
• First Posted: Jun 13, 2016
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vitiligo

Study Results

No Results Posted as of Nov 16, 2021