Spring Newsletter 2021 | Vitiligo Support International

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This Newsletter Has Been Generously Sponsored By:
Daavlin

In This Issue

Director's Message:
FDA Vitiligo Meeting - Great Success!

Support VSI

COVID-19 Vaccine and Vitiligo:
Yea or Nay?

Medicare Coverage for
Vitiligo Treatments

What's on Your Mind?

Medical News Updates

Research & Clinical Trials

Bibliography and Sources

Shop Amazon and eBay
and Earn Funding for VSI


VSI Facebook Visit VSI on Facebook

VSI Twitter And Twitter!


View Past Newsletters

VSI Medical and Scientific
Advisory Committee

  • Pearl E. Grimes, M.D., Committee Chair
  • Ted A. Grossbart, Ph.D.
  • Sancy A. Leachman, M.D.
  • I. Caroline Le Poole Ph.D.
  • Mauro Picardo, M.D.
  • Nanette B. Silverberg, M.D.
  • Richard A. Spritz, M.D.
  • Alain Taieb, M.D., Ph.D.
  • Wiete Westerhof, MD, Ph.D.

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Contact Us

Online: www.VitiligoSupport.org

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Postal Mail Address
Vitiligo Support International
P.O. Box 3565
Lynchburg Va 24503

Phone: (434) 326-5380

Message From the Executive Director

Jackie Gardner, Executive Director of VSI

Dear VSI Members, Friends, and Donors,

I’d like to begin with a round of applause for VSI members!

On 2/12/21, VSI sent out an email announcement about the (then) upcoming FDA “Patient-Focused Drug Development Meeting for Vitiligo,” and boy did you guys ever come through! By Saturday morning, my inbox was filled with messages from those of you trying to register for the event only to be notified that the event was sold out. On Monday morning, I contacted the meeting director about the situation and they had registration reopened within 24 hours!

In all, they had a record number of registrants and attendees from a wide spectrum of stakeholders.

FDA Rounded Registration Estimate

I know that all of you who participated in the meeting will agree with me that the stories from the vitiligo community were incredibly impactful. We heard from those describing feelings of identity loss, depression, and suicide; a student participating in ZOOM classrooms over the past year, but turning the camera off “to avoid prying questions;” and a caller who felt marginalized by her physician.

Several, myself included, mentioned their vitiligo spreading during COVID -19, as well as the discomfort of side effects such as itching, burning, and sleep loss. Many spoke of treatments they tried but discontinued due to problems such as lack of effectiveness, difficulty of application, and scheduling conflicts.

Poll Questions:
Click below and vote to see how your experience relates to others.

Did your vitiligo spread during the COVID-19 Pandemic?

Do you feel like your doctor understands the emotional impact of vitiligo?

Has your vitiligo ever itched?

Have you ever tried a treatment, but given up?

As a panelist, I was torn between wanting to be sure the FDA was aware of the impact and toll this disease takes on those affected, and exposing very personal information in such a public forum. I wanted them to know that no matter how well-adjusted a person may seem on the outside, the reality is that once this disease invades your life, it is always with you.

If you missed the meeting, do not worry, you still have options!


FDA - Patient-Focused Drug Development Meeting for Vitiligo

Session 1: The Health Effects and Daily Impact of Vitiligo
Panelists begin at the 47:15 mark and conclude with my personal thoughts at 1:05:15.

Session 2: Patient Perspectives on Current Approaches to Treatment
Panelists begin at 2:19:45 and conclude at 2:40:20.

In addition to the panelists, each session included callers
who shared very moving personal stories.

To watch the meeting recording at your convenience: Click Here

To view the meeting slides and results of the live polls: Click Here


It’s not too late to have YOUR VOICE heard!

You can still share your personal thoughts and experiences about the impact vitiligo has had on your life. All comments received by the May 10, 2021 deadline will be included in a meeting summary called the Voice of the Patient report, which will be publicly available on the meeting website. If you do not want your name shared, you can select the anonymous option at the end of the submission form.

Register Your Comments Here.



Support VSI

From national advocacy to personal patient support, VSI continues to represent
the voice of the patient, providing trusted and reliable resources to the vitiligo community.

As a 501(c)(3) nonprofit organization,
VSI is dependent on public funding to provide these services.

If it’s important to you that VSI continues its efforts on your behalf to:

Make sure the voice of the vitiligo patient is heard and understood,
Advocate nationally, and provide trusted, current resources like these newsletters,

Please consider a donation, large or small, to sustain this vital work.

One Voice - One Cause

Together We Can Make a Difference!

Recurring Monthly Donation One-time Donation


Sincerely,

Jackie Gardner
Executive Director


Click Here to View VSI Newsletter on Website




Vitiligo and COVID-19 Vaccine:
Yea or Nay?


Medical Disclaimer:

The content of this newsletter is provided for informational purposes only, and does not constitute or intend to substitute for professional medical advice, diagnosis, or treatment.


VSI typically provides all newsletter sources on a separate “Bibliography and Sources” page. Because of the technical, scientific, and medical nature of the information in this article, and because many of the reference pages are being updated daily, we have provided direct links to many of the sources in the body of the article. We invite our readers to review the direct sources for more thorough and up-to-date information. The information here was current as of the final editing on March 15, 2021.




Get the facts.

Over the past few months, VSI has been inundated with emails and phone calls with questions regarding the safety and/or concerns for those with vitiligo getting the COVID -19 vaccine.

The primary concerns seem to be from those who are worried that getting the COVID -19 vaccine could be dangerous because of having vitiligo and/or other autoimmune diseases. Others expressed concern that having health problems in addition to vitiligo could mean that their immune system was weakened or compromised, making the COVID -19 vaccine a dangerous option. We’ve included a few of the questions received, along with information we hope will be helpful in addressing the concerns.

“I would like to know if I should take the vaccine with vitiligo and psoriasis.
I feel like my immune system is really compromised.”

-VSI Member L.S.

Am I Immunocompromised?

Many conditions and treatments can weaken a person’s immune system, making them “immunocompromised.”

Some of these include:

Cancer, Bone marrow transplant, Solid organ transplant,
Stem cells for cancer treatment, Genetic immune deficiencies, and HIV

Use of oral or intravenous corticosteroids or other (systemic) medicines called immunosuppressants that lower the body’s ability to fight some infections (e.g., methotrexate, rituximab, cyclosporine, etanercept, and prednisone).

People with weakened immune systems are at higher risk of getting severely sick from the virus that causes COVID -19. They may also remain infectious for a longer period of time than others with COVID-19.

Source: CDC: If You Are Immunocompromised, Protect Yourself From COVID-19.

According to the CDC: “Persons with HIV infection or other immunocompromising conditions, or who take (systemic) immunosuppressive medications or therapies, might be at increased risk for severe COVID-19. Data are not currently available to establish vaccine safety and efficacy in these groups. Persons with stable HIV infection were included in COVID-19 vaccine clinical trials, though data remain limited. Immunocompromised individuals can receive COVID-19 vaccination if they have no contraindications to vaccination. However, they should be counseled about the unknown vaccine safety profile and effectiveness in immunocompromised populations, and the potential for reduced immune responses and the need to continue to follow all current guidance to protect themselves against COVID-19.”

Many of those contacting VSI have asked about “research” specifically relating to the safety of those with vitiligo receiving this vaccine. I can promise you that at this stage, all-hands-on-deck are researching the safety and efficacy (effectiveness) of the vaccine in the general population, not among those with vitiligo. Generally speaking, those with vitiligo would fall under the broader category of those with autoimmune disease.

Keep in mind that this time a year ago, the words quarantine and pandemic were not even in day-to-day language. In the past 12 months, we’ve gone from being told there’s nothing to really worry about to half a million deaths and three vaccines approved under Emergency Use Authorizations. Not surprisingly, the information being released is all over the place.

Other confusion seems to stem from
mixed messaging from some of the top experts.

“Are vitiligo patients in a high-risk group for the coronavirus? Also, what are the risks or benefits to us of taking the vaccine? I have held off due to fear that it could cause serious results to us because no autoimmune people were in the studies.”
 
Camille Rendal Webb: VSI Member and Supporter Since 2006

The topic of those with autoimmune (A/I) diseases being excluded from the vaccine clinical trials is a primary example of mixed-messaging. The reality is that this is an inaccurate statement. Some people with some A/I diseases were excluded from the clinical trials due to customary clinical trial protocol.

There are multiple phases of clinical trials required prior to FDA drug authorization.

Some phases (1, 2, and 3) having to do with the safety and efficacy of a drug in the general population are carried out prior to drug authorization. Others are typically carried out after authorization, in phase 4 (post-marketing phase), which is when you would see testing in the smaller sub-groups. If they included all sub-groups in the early trials, they could get skewed results.

Due to the rising numbers of deaths from the COVID-19 virus, the world governments were anxious to bring vaccines to market. After the first 3 phases of clinical trials, the FDA issued the Emergency Use Authorizations (EUA) for the Pfizer and Moderna Mrna COVID-19 vaccines, and on February 27, the FDA also issued a EUA for the single-shot Johnson & Johnson/Janssen viral vector vaccine.

COVID-19 vaccine clinical trials did involve people with A/I conditions that are manageable without taking systemic immunosuppressant drugs – this would include those with conditions like vitiligo. None of the COVID-19 clinical trials segregated those with this type of A/I disease in their data, meaning they did not separate the statistics for those in this group from the rest of the general population data of all those in the trial group.

However, those with A/I conditions who were on immunosuppressant drugs were excluded because these drugs, as noted in their name, suppress the immune response and can reduce “the body’s ability to mount a robust immune response to a COVID -19 vaccine.” So they wouldn’t want those stats skewing the results of efficacy from the general population.

Is it Safe for Those Taking Immunosuppressive Drugs
to Receive the COVID-19 Vaccine?

Even with these possibilities, Sarfaraz Hasni, MD, director of the Lupus Clinical Research Program at the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health in Bethesda, Maryland says, “My general recommendation is to get the vaccine. Even if you may not have full protection, it’s probably still better to get it than not to get it.”

Is it Safe for People with Autoimmune Disease
to Receive the COVID-19 Vaccine?

COVID-19 & Autoimmune Disease

Gregory Poland, MD, a vaccinologist at Mayo Clinic in Rochester, Minnesota, and the director of Mayo Clinic’s Vaccine Research Group, says: “I’d say someone with an autoimmune disease would be at much higher risk from complications of being infected with Covid-19.” “Until we have data to the contrary, for the majority of people with autoimmune disease, their risk of complication from infection is far higher than the observed teeny risk attributable to any of the Covid vaccines.”

Patrick Hanaway, MD, a family physician in Asheville, North Carolina, and senior adviser to the CEO of the Institute for Functional Medicine agrees, adding: “the potential for SARS-CoV-2 infection to lead to post-Covid-19 syndrome (lingering symptoms suffered by so-called long-haulers) is all the more reason for people with autoimmune disease to opt for vaccination.”

COVID-19 VACCINE INFORMATION


Who Should get a COVID-19 Vaccine?

The Centers for Disease Control and Prevention (CDC) developed the “COVID-19 Vaccine Rollout Recommendations” prioritizing those they felt were most vulnerable to an increased risk of developing severe* illness from the virus that causes COVID-19.

*Severe illness from COVID-19 is defined as hospitalization, admission to the ICU, intubation or mechanical ventilation, or death.

Healthcare personnel, residents of long-term care facilities, frontline essential workers, adults aged 65 and older, and those aged 16—64 years with underlying medical conditions, should be prioritized to be vaccinated as early as possible. (While these are the recommendations of the CDC, individual states can and do set different priorities. Check your state’s health department website for the priorities in your state.)

To see a list of underlying medical conditions identified as possibly putting adults of any age at an increased risk of severe illness from the virus that causes COVID-19, click here.

As time goes on and more approved vaccines and/or more doses are available, more of the population outside the above groups will become eligible to receive the vaccine. Women who are pregnant or lactating should consult their health care provider prior to receiving a vaccine.

Who Should NOT get a COVID-19 Vaccine?

Anyone who has ever had an allergic reaction to any vaccine.

Contraindications (Medical reasons to avoid the COVID-19 vaccine)

CDC considers a history of the following to be a contraindication to vaccination
with the Pfizer-BioNTech, Moderna, and Johnson & Johnson’s COVID-19 vaccines:

Severe allergic reaction (e.g., anaphylaxis) after a previous dose
of any COVID-19 vaccine or any of its components

Immediate allergic reaction of any severity to a previous dose of any COVID-19 vaccine
or any of its components (including polyethylene glycol [PEG])*

Immediate allergic reaction of any severity to polysorbate
(due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

* These persons should not receive a COVID-19 vaccination (Pfizer-BioNTech, Moderna, or Johnson & Johnson) at this time unless they have been evaluated by an allergist-immunologist and it is determined that the person can safely receive the vaccine (e.g., under observation, in a setting with advanced medical care available).

Authorized age groups:

Under the “Emergency Use Authorization,” the following age groups
are currently authorized to receive the COVID-19 vaccination:

Pfizer-BioNTech: ages ≥16 years
Moderna: ages ≥18 years
Johnson & Johnson/Janssen: ages ≥18 years

Children and adolescents outside of these authorized age groups
should not receive COVID-19 vaccination at this time.

Administration

The Pfizer and Moderna mRNA COVID-19 vaccines include two doses administered intramuscularly:
The Johnson & Johnson/Janssen viral vector vaccine, by contrast, consists of a single dose.

Pfizer-BioNTech (30 micrograms, 0.3 ml each): 3 weeks (21 days) apart
Moderna (100 micrograms, 0.5 ml): 1 month (28 days) apart
Johnson & Johnson/Janssen (single dose of) 0.5 mL

For Additional Information on Viral Vector Vaccines: Click here.


mRNA (Messenger RNA) Vaccine

mRNA vaccines are a new type of vaccine to protect against infectious diseases. To trigger an immune response, many vaccines put a weakened or inactivated germ into our bodies. Not mRNA vaccines. Instead, they teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.

*COVID-19 mRNA Vaccine Facts:
Do not use the live virus that causes COVID-19
Cannot give a person COVID-19
Do not affect or interact with our DNA in any way.

*The above facts apply only to the Moderna and Pfizer vaccines.

Source: CDC: Understanding mRNA COVID-19 Vaccines


COVID-19 Vaccine: Side Effects


CDC COVID-19 Side Effects

First dose: Most people experience only minor side effects such as soreness and/or swelling at the site of injection within a few hours after receiving the first dose, which typically subsides within 24-48 hours.

Second dose: It is more common for the second dose to cause more systemic discomfort than the first. In addition to soreness at the injection site, side effects of the second dose can include fever, chills, headache, fatigue, muscle and joint pain, but typically resolve within 24-48 hours.


Systemic: Affecting areas of the body beyond just the site of injection.

See below for additional information on the type of
reactions seen with the COVID-19 vaccines.

Pfizer COVID -19 Vaccine Reactions
Moderna COVID -19 Vaccine Reactions
Johnson & Johnson COVID -19 Vaccine Reactions


Why do some people experience
much stronger reactions than others?

According to Purvi Parikh, MD, an immunologist at NYU Langone Health in New York City, the more intense reaction from the second dose is common for everything from vaccines to allergies. The first time the immune system is exposed to a foreign substance, it begins building the immune response. By the time the second dose is administered, the immune system recognizes the substance and begins waging an attack.

Though the stronger side-effects may seem unpleasant at the time, they actually indicate
a positive reaction resulting from a stronger, more robust immune response.

Young adults more often experience the stronger side effects, as they generally have a stronger immune system. The more intense second-dose side effects are less common in those over the age of 65 due to the typical weakening of the immune system that comes with age.

Beware of Medication!

Avoid Pain Relievers Before Getting COVID-19 Vaccine

Researchers advise that after symptoms occur it is OK to take pain relievers such as acetaminophen or ibuprofen.
However, they should be avoided prior to the vaccination.

A January 2021 study published in the Journal of Virology found that nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen/Advil or naproxen/Aleve reduced antibody production as well as other aspects of the virus that causes COVID-19 immune response.

Dr. Poland says the CDC has also recommended against the use of antihistamines such as Claritin or Zyrtec prior to taking the vaccine because “they could mask the onset or development of allergic or hypersensitivity reactions."

Dr. Colleen Kelley (not affiliated with the above study), an associate professor of medicine at Emory University School of Medicine, hypothesized that taking the medications could reduce the desired inflammatory response caused by the immune system’s reaction to the vaccine, thus reducing its effectiveness.

A 2016 study from Duke University looked at the effectiveness of various children’s vaccines and found that those who took pain relievers before receiving routine inoculations had fewer antibodies than those who did not.

Patrick Hanaway advises, “If you feel dizziness, fatigue, a low-grade fever, that’s the innate immune system responding appropriately. Let the body have the immune reaction — that’s what will give you protection.”

Should YOU get a COVID-19 Vaccine?


COVID-19 Vaccine


Which Group do You Fall Into?

Group 1:
Persons who are aged 16-64 years with an underlying medical condition, or aged 65 or older, have been prioritized to receive the vaccine earlier than the general population because of being vulnerable to an increased risk of developing severe illness from the virus that causes COVID-19.

Group 2:
All persons that fall within their states authorized age groups and have never had an allergic reaction to any vaccine, should also receive a COVID-19 vaccination at the earliest available opportunity, unless otherwise instructed by their medical provider.

Group 3:
Persons who ever had an allergic reaction to any vaccine should not receive the COVID-19 vaccination (Pfizer-BioNTech, Moderna, or Johnson & Johnson) unless they have received a medical evaluation from an allergist-immunologist and been cleared to safely receive the vaccine.

Group 4:
Those who are unsure which group they are in, have unique health complications, or are simply concerned about how their immune system might respond to the COVID-19 vaccine, should discuss the situation with their health care provider before making a decision.

The bottom line is that you and your medical provider are in the
best position to know what is best for you and your health.


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Calling all Medicare Vitiligo Patients!


VSI regularly hears from patients from all over the United States who have been denied insurance coverage for their vitiligo treatment. VSI has been fighting this battle on a national level for several years. While we are definitely making progress, it’s been a slow road.

Part of the problem is that currently there is no accepted standard for coverage of vitiligo treatments. Each company has their own policies and guidelines, many times based on outdated and incorrect information.

What most people may not realize is just how much private insurance coverage can be affected by Medicare policies. Over 55 million Americans are now covered by Medicare or Medicare Advantage, making it the nation’s largest health insurance program  Consequently, many, if not most, insurance providers establish their baseline standards and procedures to follow the Medicare model.

Medicare has agreed to meet with us – but requires that we bring Medicare letters of denial for a vitiligo treatment.

If you are reading this newsletter and you, or someone you know, was denied coverage for a vitiligo treatment by Medicare, please contact VSI immediately. You could help make a difference for future insurance coverage for ALL vitiligo patients! Click Here to Contact VSI


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What's On Your Mind?


Is Spray-On Hair Color Safe to Use With Vitiligo?

L'Oreal Q. I’ve read in many of VSI’s newsletters over the years about commercial hair dyes causing pigment loss for those with vitiligo. My question is about one of the newer products on the market that I’m hoping might be safe. Do you know anything about the temporary “spray-on” hair products?

A.  This is a great question!
When asked if the ingredient list (shown below) for a popular L’Oreal spray on hair color product contained any of the phenol chemicals associated with triggering vitiligo, Dr. John Harris, one of the leading authorities on chemical-induced vitiligo, replied that “nothing looked suspicious,” leading him to believe the product should be OK to use.

L'Oreal Active Ingredients


Previous VSI Newsletter Report on Permanent Hair Dyes and Vitiligo


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Medical News Updates

Highlights of recently-published medical
articles on vitiligo and its treatments


Ruxolitinib Update

Ruxolitinib is topical, nonsteroidal, anti-inflammatory,
Jak inhibitor cream currently in phase 3 clinical trials for use in vitiligo

Ruxolitinib

As VSI reported in our Summer 2019 newsletter, research shows that when the JAK signaling pathway becomes over-active, it drives the inflammation associated with triggering both the onset, and subsequent progression of vitiligo. The goal of the ruxolitinib cream is to reduce or block this process.

Jim Lee, MD, Group Vice President, Inflammation & Autoimmunity at Incyte (drug manufacturer) reported:
“We are very encouraged about the positive updated data which demonstrate substantial facial and total body repigmentation of vitiligo lesions in patients treated with ruxolitinib cream, and continued improvements with longer duration of treatment. As we seek to offer a much-needed option for those patients impacted by this life-altering disease, we are excited that the pivotal Phase 3 studies evaluating ruxolitinib cream in patients with vitiligo are underway, with results expected in 2021.”

Ruxolitinib Phase 2 Clinical Trial Outcome:

Ruxolitinib cream was generally well-tolerated at all dosage strengths
and no treatment-related serious adverse events were reported.

Results for participants using 1.5%
Ruxolitinib cream twice a day for 52 weeks:

51% experienced at least 75% improvement in their facial vitiligo
90% experienced at least 33.3% percent improvement in their facial vitiligo

36% of all patients experienced at least a 50% improvement in total body vitiligo, while 45% of patients with less than 20% total body coverage experienced at least a 50% improvement.

If the Phase 3 trials are successful, a supplemental new drug application (sNDA) submission could take place in the second half of 2021. A sNDA is an application required by the FDA to add a new indication (vitiligo) to the labeling of an approved drug. The FDA targets a 10 month review timeline for sNDAs.




Congratulations!

Jackie Gardner, Executive Director of VSI VSI would like to congratulate Dr. John Harris, associate professor of dermatology, and one of the nation’s foremost authorities on the treatment and study of vitiligo, on his new appointment as Chair of the Department of Dermatology at the University of Massachusetts Medical School (UMMS) in Worcester, MA.

Dr. Harris directs the Vitiligo Clinic and Research Center at UMMS, which incorporates a specialty clinic for the diagnosis and treatment of patients with vitiligo, as well as a vitiligo research laboratory. He uses basic, translational, and clinical research approaches to better understand autoimmunity in vitiligo, with a particular focus on developing more effective treatments.

Dr Harris is no stranger to VSI members, as you’ve read about many of his research efforts over the years in VSI newsletters, including announcements inviting participation in his recruiting clinical trials.

Recognized as a leader in research efforts of JAK-inhibitors for vitiligo treatments, his contributions have led to systemic JAK inhibitors such as ruxolitinib and tofacitinib becoming reformulated as topical creams in an effort to only treat the area to which they are applied, thereby reducing systemic side effects.

Dr Harris has also been gracious enough to assist VSI as a medical consultant on a great number of newsletter articles over the years, providing medical analysis and clarification on articles such as the COVID-19 Vaccine/Vitiligo article in this newsletter.

His contributions to date have unquestionably made a tremendous impact on the advancement of vitiligo treatments. I can only imagine what the future will bring!

Congratulations on this hard earned, well-deserved promotion!


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Research & Clinical Trials


New Vitiligo Treatment Clinical Trial
Irvine, California

Phase 2 Clinical Trial Evaluating
AMG 714 Treatment for Vitiligo

Study Location:

UCI Health Beckman Laser Institute and
Medical Center, Suite 222
Irvine, California, 92697

As VSI has previously reported, many times when a person experiences a vitiligo relapse, they lose pigment in the exact same location as a previous lesion, due to the discovery of autoimmune memory T cells. This new therapy targets and blocks the memory signaling and also removes these memory T cells, which is showing long-term improvement from short-term therapy.

Participants will be randomized into one of two groups for a 24 week, double blind period.

Each group will receive 300 mg of AMG 714, or, placebo for AMG714, subcutaneously
on Day 0 and every 2 weeks thereafter through week 10 (for a total of 6 doses).

At week 24, all participants who have not shown at least 25% improvement,
will begin NB-UVB phototherapy 3 times per week for a total of 24 weeks.

Key Inclusion Criteria:

  • Clinical diagnosis of active or stable non-segmental vitiligo
  • At least 3% depigmentation on the body
  • Must be willing to undergo narrow band ultraviolet B (nbUVB) phototherapy
  • Must discontinue all vitiligo treatments from screening through the final safety follow-up visit at week 48

Key Exclusion Criteria:

  • More than 33% pigment loss on the face or on the total body
  • Previous or current diagnosis of other cancer
  • May never have used any depigmentation treatments


To participate, or for more information:
Contact: Narinder Singh - Phone: 949-824-6483 - Email: [email protected]



NEW! RECELL Clinical Trial
Irvine, California

RECELL Clinical Trial
for Stable Vitiligo

Study Location:

UCI Health Beckman Laser Institute and
Medical Center, Suite 222
Irvine, California, 92697

The purpose of this study is to evaluate the application of Spray-On Skin™ Cells, prepared using the RECELL Device, for safe and effective repigmentation of stable vitiligo.

At the initial visit, a thin shave of normal skin is obtained (using lidocaine). The healthy melanocytes are extracted and mixed with a solution, which is then applied to the prepared depigmented area, and covered with a dressing.

After 1 week, participants will return for dressing removal and to begin NB-UVB light therapy.

Phototherapy will continue 3 times each week for 1 month, then 2 times each week for another 2 months, using a provided home phototherapy device.

After the dressing is removed, participants will return for a total of 5 more visits,
at or around the following schedule: Week 4; Week 12; Week 24; Week 36; and Week 52.

Key Inclusion Criteria:

  • Must be at least 18 years of age
  • Must have focal, segmental or generalized (i.e., nonsegmental) vitiligo
  • Vitiligo must have been stable (no change) over previous 12 months

Key Exclusion Criteria:

  • May not be pregnant
  • May not have depigmented fingertips
  • May not have greater than 30% total body pigmentation
  • May not be using anticoagulant medications (such as heparin or warfarin)


To participate, or for more information:
Contact: Narinder Singh - Phone: 949-824-6483 - Email: [email protected]


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Earn Funding for VSI with Amazon and eBay


Online Shopping Can Benefit VSI!

Amazon Shopping for VSI

With thousands of items in addition to books, Amazon.com is a one stop-shopping center! Simply shop through the above link (bookmark it for easy reference) and VSI will earn fees, based on a percentage of the sale. The more items purchased by members, the higher the percentage!

Tobi Cares Donation Program

Tobi is an online women's clothing design label that brings LA style from its design studio direct to its online clothing store at tobi.com. Go to Tobi Cares and sign up for VSI to receive 1% of your purchase amount.

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GOODSEARCH SHOPPING AND DINING!

GoodSearch and Goodshop, like iGive, offers coupons, discounts, and donations to VSI through its network of over 5,000 stores. Just click the link above to get the savings started and the donations flowing!

* Vitiligo Support International Inc. (VSI) is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.


Earn Funding for VSI with eBay



Support VSI with eBay!

Do you sell items on eBay, or want to hold an online garage sale? If so, consider donating a percentage of your proceeds to VSI through eBay’s Giving Works program! It’s easy – when you list an item through a Giving Works listing, choose to send 10-100% of the final sale price to VSI. Your listing will have a special placement and designation. You’ll receive a proportional fee credit from eBay, and will also receive a tax donation receipt when the donation is deducted from your funds received. It’s a great opportunity to make some money for yourself and for VSI, so clean out those closets and garages and get selling!

To Learn More About VSI's Giving Works: Click here


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