VitiligoNCT02797574
Stress Response Pathways in Vitiligo
A study testing Punch Biopsy at a Lesional Site and Punch Biopsy at a Non- Lesional site in people with Vitiligo, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Punch Biopsy at a Lesional Site and Punch Biopsy at a Non- Lesional site
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 22 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- Punch Biopsy at a Lesional Site, Punch Biopsy at a Non- Lesional site
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch Biopsy at a Lesional SiteProcedure or surgery
Punch Biopsy at a Non- Lesional siteProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo Diagnosed Group | Active comparator | Clinically diagnosed with non-segmental vitiligo Receives: 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 Receives: Procedure: Punch Biopsy at a Non- Lesional site |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)
Measured: 1 Year
Secondary outcomes (1)
T-test measures of expression levels in response to Vitiligo triggers
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startOct 2015
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prashiela Manga, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797574
- Sponsor's protocol ID
- 15-00445
- Status last verified
- Nov 2021
- First submitted
- 4 Feb 2016
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Response Pathways in Vitiligo: A Prospective, Investigator Initiated, Interventional Study With Two Arms
- ClinicalTrials.gov ID
- NCT02797574
- Acronym / sponsor ID
- 15-00445
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitiligo Diagnosed Group | Active comparator | Procedure: Punch Biopsy at a Lesional Site, Procedure: Punch Biopsy at a Non- Lesional siteClinically diagnosed with non-segmental vitiligo |
| Healthy Control Group | Active comparator | Procedure: Punch Biopsy at a Non- Lesional site20 normally pigmented control subjects who are between the ages of 18 and 50 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Punch Biopsy at a Lesional Site | Procedure or surgery | Vitiligo Diagnosed Group |
| Punch Biopsy at a Non- Lesional site | Procedure or surgery | Healthy Control Group, Vitiligo Diagnosed Group |
Primary outcome
T-test measures of expression levels of target proteins in patients versus controls (p < 0.05)
Time frame: 1 Year
1 secondary outcome
T-test measures of expression levels in response to Vitiligo triggers
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashiela Manga, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punch Biopsy at a Lesional Site and Punch Biopsy at a Non- Lesional site in people with Vitiligo, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-test measures of expression levels of target proteins in patients versus controls (p < 0.05) (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.