In This Issue
VSI Earns 2025
Gold Seal of Transparency
Game-Changing Discovery
Revolutionary Breakthrough
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, M.D., Ph.D Honorary/Deceased
Contact Us
Online: www.VitiligoSupport.org
Email: Contact Us
Postal Mail Address
Vitiligo Support International
P.O. Box 3565
Lynchburg Va 24503
Phone: (434) 326-5380
Message from the Executive Director
Dear VSI Members, Friends, and Donors,
For several years, when I attended the vitiligo sessions at the American Academy of Dermatology (AAD) Annual Meeting it seemed that although researchers were working very hard on our behalf and making important discoveries, their findings didn’t really translate into breaking news to the average, non-scientific attendee.
However, that all began to change in 2018. I recall having dinner with a dermatologist from Israel one evening, and with a light tone of skepticism, he asked if I’d learned anything new from the meetings I’d attended. I replied that yes, in fact I had! He raised his brow as if to question the news.
I took a stab at relating to him the news of these “memory T cells” located in skin that had previously been depigmented. It was thought to have something to do with the relapse of regained pigment. “Interesting,” he said.
In previous years, there had been so much energy and expectation surrounding the potential of biologics, statins, and JAK inhibitors, but the path was littered with ups and downs. New discoveries anticipated to be transformative were interspersed with unforeseen complexities and red herrings.
Turning
Point
In a whirlwind of positive results, so many pieces seemed to suddenly be falling into place. Within a year, vitiligo had a phase 2 clinical trial for a topical JAK inhibitor treatment, and by 2021, the phase 3 results were in and declared “very positive!”
A Year Later in July 2022, Opzelura, a topical JAK inhibitor, Received FDA-Approval
As the First On-Label Treatment for the Repigmentation of Vitiligo!
Research and development in the field of JAK inhibitor treatments continued at an unprecedented pace. It was this intense scrutiny that led to a revolutionary breakthrough that could move treatment beyond temporary fixes, possibly even cracking the door to permanent recovery.
Inside This Newsletter
Discover how this groundbreaking therapy could change the future of vitiligo, and how you could be among the first to help test whether lasting repigmentation is finally within reach!
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Executive Director
Congratulations VSI:
Awarded 2025 Gold Seal of Transparency!
VSI has earned the 2025 Gold Seal of Transparency with Candid.org, a high-level recognition for transparency from Candid (formerly GuideStar), a leading platform for nonprofit information.
The Gold Seal signifies that Vitiligo Support International has provided comprehensive information about its mission, programs, finances, and other key aspects, demonstrating a commitment to transparency, according to Candid.
Revolutionary Breakthrough
“One of vitiligo’s greatest mysteries, as well as frustrations, has been why pigment that has been regained with treatment remains susceptible to relapse, even many months or years later. Especially intriguing to researchers is why these recurrences often appear in the exact places where the vitiligo was previously located.”
The above paragraph is from a 2018 VSI newsletter article
when we first reported on the mystery of recurrent pigment loss.
Researchers had uncovered so many of the key elements related to the autoimmune sequence that triggers the onset of vitiligo, but there were still gaps of clarity on the relationship between that original process and what triggered a relapse.
While there are many factors involved with the timing of relapsed pigment loss, vitiligo is designated a chronic disease, meaning that it can be treated and managed, but not cured. It is also referred to as cyclical, meaning there will be periods of stability and periods of activity throughout life.
The 2018 article announced the discovery of resident memory T cells (Trm), revealing that after the immune system attacks melanocytes (pigment-making cells) resulting in the hallmark areas of pigment loss, specialized memory cells remained permanently at that very location, ready to jump into action in the future.
What Are T Cells?
T cells are white blood cells that act as defenders, specifically trained to recognize and fight off foreign invaders like viruses, bacteria, and even cancer cells.
With autoimmune disease, the body’s immune system mistakenly identifies some part of the body as foreign or dangerous. With vitiligo, melanocytes are targeted. As a result, T cells target and attack these pigment cells.
T Cell Subsets
Memory T cells are like neighborhood watch dogs, offering long-term protection. Once the immune system has experienced an intruder such as a virus or infection, memory T cells go to work setting up surveillance to protect against any future threats.
For instance, once you’ve had the flu, if you are re-exposed, memory T cells immediately alert the immune system to mount an attack to prevent or lessen the symptoms of reinfection.
Unfortunately, this protection can become counterproductive with autoimmune diseases, when the body has mistakenly identified something in its own tissues as foreign. In this case, memory T cells become autoreactive, producing an immune response against some part of the body’s own tissues.
Resident Memory T Cells (Trm) are specialized memory cells. Their biggest difference is that instead of surveilling the entire body for intruders, these T cells are assigned only to specific tissues, becoming a resident of the site where the original immune response occurred. This allows them to accelerate their activation time and respond more rapidly.
Watershed Moment
The Trm discovery significantly altered many previously held concepts and marked a major shift in the direction of treatment research. Not only had they learned that Trm were responsible for triggering relapse, but they also discovered that the longer the Trm remained undisturbed (untreated), the greater their accumulation.
A 2019 research article about Trm stressed the importance of early (treatment) intervention, saying: “vitiligo could be seen as an emergency disease needing an early intervention during the initiation of the disease to prevent this inadvertent accumulation of resident (memory)T cells.”
Evolution of Targets
Prior to the discovery of Trm, JAK inhibitor research had been focused on blocking the JAK pathway used by interferon-gamma (IFN-γ), a pro-inflammatory cytokine (signaling protein) responsible for triggering and increasing inflammation while recruiting and increasing killer T cells leading to the programmed cell death of melanocytes.
Blocking the IFN-y pathway allowed the melanocytes to flourish and the skin to repigment. However, as mentioned above, when/if a relapse is triggered, regained pigment from any/all of the treatments, including JAK inhibitors, remained susceptible.
Researchers saw the discovery of the Trm as a revolutionary breakthrough, raising the possibility that if these Trm cells could be blocked or disabled, then once pigment was returned, theoretically it could be maintained long-term, or even permanently.
Operation Target Trm
Research became intensely focused on the specific steps of the autoimmune sequence involving Trm. In just a few months, the scrutiny paid off with the discovery of Interleukin-15 (IL-15), another small signaling protein (cytokine) also focused on activating and increasing killer T cells, but, with a specific priority to support and maintain resident memory T cells (Trm) in the skin.
They found that if they blocked or removed access to IL-15, the Trm could not survive. Even blocking short term access resulted in significant, long-term improvement!
They delved deeper into the IL-15 process essential for Trm survival, which led to the pivotal discovery that JAKs are responsible for delivering the vital IL-15 life support and there is only one exclusive pathway that can be used to deliver the Trm cells to maintain the inflammation, and that is the JAK pathway!
If the JAK Pathway is open, IL-15 life support can be safely delivered and the Trm cells survive. But if the JAK pathway is blocked for any reason and the life support can’t be delivered, then the Trm cells begin losing their strength and ability to function.
To Better Understand JAK Inhibitors and How They Work for Vitiligo,
See “Emerging Game-Changer” Article Below
Includes New Clinical Trial Results for Baricitinib, Another JAK inhibitor
A Paradigm Shift
The discovery of resident memory T cells (Trm) and the evolution of treatment targets from IFN-γ to IL-15 signaled a major turning point in vitiligo research, a true paradigm shift.
The development of JAK inhibitor treatments had marked the first ever clinically effective, immune-targeted treatment for vitiligo.
This was a giant leap forward, as JAK inhibitors are focused on modifying immune responses by targeting specific immune cells, rather than suppressing the entire system as with traditional immunosuppressants of the past. This new strategy reduced the attack on the body’s own tissues, while preserving immune function needed for other purposes.
JAK inhibitors were particularly successful in blocking much of the inflammation and T cell activity caused by IFN-γ, though they were less effective against IL-15. Pre-existing Trm cells became dormant and no new Trm cells formed while on treatment, but once treatment stopped, pre-existing Trm cells began regaining their strength, and new Trm cells began to form.
Now the focus evolved strategically. Rather than directly targeting the Trm cells, researchers found that by targeting IL-15, (with anti-IL-15 therapies) Trm cells were removed, vitiligo reversed, and pigment remained long term.
Introducing Anti-IL-15 Therapies
Considered the next generation of treatments, anti-IL-15 therapies use monoclonal antibodies, which are engineered proteins designed to selectively block IL-15 from reaching and providing life support to the Trm cells.
What is the Current Status of These Treatments?
Just 3 years ago, we were anxiously awaiting approval of the first FDA-approved treatment for the repigmentation of vitiligo. As of May 2025, there are at least three notable monoclonal antibody therapies under investigation for the treatment of vitiligo.
Although they are all designed to block Trm survival by targeting elements of IL-15 signaling, there are slight variations in the specific targets.
Anti IL-15 Monoclonal Antibody Therapies
in Development for Vitiligo
Auremolimab: Began its first human clinical trial for vitiligo around the beginning of November 2023. Clinical development continues, but no trials appear to be currently recruiting.
AMG-714: Clinical trials began in December 2020. The study, now in Phase 2, is active, but not recruiting. VSI included recruitment announcements in two of our past newsletters for AMG-714.
TEV-53408: Clinical trials began in November 2024. The study, now in Phase 1b, is active and recruiting.
Scroll down to the Clinical Trial Announcements below to see if you are eligible to participate in the TEV-53408
JAK Inhibitors Currently Available by Prescription for Vitiligo
Opzelura: (ruxolitinib phosphate 1.5%) Topical JAK inhibitor, is the first and only FDA-approved treatment for vitiligo.
Ruxolitinib Phosphate 1.5%: Topical JAK inhibitor. This is the active ingredient found in Opzelura. Because Opzelura is a new medication, its formula is still protected by patent, meaning it is not available in a generic form. However, ruxolitinib phosphate 1.5% is available from compounding pharmacies in a formulation slightly different from Opzelura.
According to the Association for Accessible Medicines, “A generic drug is identical or bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”
Tofacitinib: (Sold as Xeljanz) is an FDA-approved oral treatment for several conditions, including rheumatoid arthritis and psoriatic arthritis, but is currently available only as “off-label” for use for vitiligo. In a 2024 review of Jak inhibitors used for vitiligo, tofacitinib was listed as one of the two most often studied. There have been multiple case reports and pilot studies showing the safety and efficacy for the use of oral and topical tofacitinib for use for vitiligo. Many dermatologists prescribe compounded topical tofacitinib for their vitiligo patients.
VSI can provide contact information for a reputable compounding pharmacy that routinely makes and ships medications (only within United States, Puerto Rico and Guam) such as ruxolitinib, tofacitinib, and monobenzone.
Jak Inhibitors Currently in Development for Vitiligo
Deucravacitinib: Oral JAK inhibitor, currently in Phase 3 clinical trials for vitiligo
Povorcitinib: Oral JAK inhibitor, currently in Phase 3 clinical trials for vitiligo
Ritlecitinib: Oral JAK inhibitor, currently in Phase 3 clinical trials for vitiligo
Ruxolitinib Phosphate 1.5% Cream: Phase 3 Pediatric clinical trial for vitiligo
Scroll down to the Clinical Trial Announcements below to see if your child is eligible to participate in the Pediatric Ruxolitinib Phosphate clinical trial.
Upadacitinib: Oral JAK inhibitor, currently in Phase 3 clinical trials for vitiligo
Baricitinib: Oral JAK inhibitor, currently in Phase 2 clinical trials for vitiligo
See the “Emerging Game-Changer” article below for Update on Phase 2 Results!
VSI would like to thank Lars Brichta, PharmD, PhD
for his guidance and expert advice on this article.
for Severe Vitiligo
Stabilizes and Restores Pigment
If you are new to the world of vitiligo, please be encouraged to know that these are truly exciting times.
Thanks to decades of research and the dedication of the many brilliant scientists in our community, in 2022, we finally got our first FDA-approved on-label treatment for the repigmentation of vitiligo. But what that represented was far greater than the treatment itself. The research discoveries that identified the pathways responsible for the development of vitiligo also led to a new class of drugs, called Janus kinase (JAK) inhibitors.
What Are Janus Kinases (JAKs)
Why Do They Need to be Inhibited?
Janus Kinases (JAKS) are intracellular enzymes that play a key role in the immune system and inflammation contributing to the autoimmune sequence resulting in pigment loss. JAKs help carry the signals that instruct the immune system to attack melanocytes. They act like amplifiers, boosting the response to these signals and causing the immune system to escalate the attack, like a stuck gas pedal keeping pigment loss in overdrive.
The 2022 FDA-approved treatment (Opzelura) is just one of the new JAK inhibitors (JAKi’s) being investigated for treating chronic inflammatory skin disorders like vitiligo.
How Do JAK Inhibitors Work for Vitiligo?
First, it’s important to understand that vitiligo is an autoimmune (A/I) condition where the body’s own immune system begins mistakenly attacking its own melanocytes (pigment-making cells), causing pigment loss.
Imagine melanocytes as tiny skin painters responsible for adding color to your skin. In vitiligo, the immune system mistakenly sees these painters as enemies and attacks them with inflammation like a fire burning through their workspace.
A JAKi is a type of medication that blocks the activity of Janus kinase (JAK) enzymes. By inhibiting these enzymes, JAKi’s work to reduce inflammation and block the overactive A/I response that is causing the destruction of the melanocytes.
Inflammation Causes Two Major Problems:
1. Destroys melanocytes – The attack kills many of these pigment-producing cells, leaving behind white patches on the skin.
2. Prevents new melanocytes from growing – Even if some painters survive or new ones try to move in, the ongoing fire (inflammation) makes it hard for them to work, grow, or spread color back into the skin.
As long as this inflammation continues, it’s difficult for the skin to regain its natural color. Treatments like systemic JAKi’s are like fire retardants, helping by suppressing the fire and giving melanocytes a chance to return and start painting again.
The 2022 FDA-approved treatment (Opzelura) was the first of several JAKi’s being investigated for treating chronic inflammatory skin disorders like vitiligo.
This Treatment Update is for a Phase II Clinical Trial Evaluating the Safety and Effectiveness of Baricitinib Combined with Narrowband (NB) UVB.
What is Baricitinib?
Baricitinib, the generic form of a drug already on the market (brand name Olumiant), is an oral JAKi. It first became FDA-approved for use for rheumatoid arthritis on May 31, 2018, followed by COVID-19 in May 2022, alopecia areata in June 2022, and is currently in clinical trials for a number of other conditions, including vitiligo.
How is This Vitiligo Clinical Trial/Treatment Different from Others?
Vitiligo treatments and clinical trials have historically
involved topical treatments applied twice daily.
Baricitinib is an Oral Tablet
Taken Once Daily
Most clinical trials include only participants with stable disease
(no new pigment loss for at least 6 months)
This clinical trial was specifically for adults with actively
spreading vitiligo, because they are the most difficult to treat.
Most clinical trials are for those with limited areas of pigment loss.
This clinical trial was for those with extensive pigment loss.
What is the Difference Between
Oral Systemic and Topical Treatments?
Oral Systemic Treatments
Taken by mouth and travel through the bloodstream to
impact the body’s immune response.
Topical Treatments
Applied directly to the affected skin, suppressing the
immune response only where they are applied.
Which is Better?
That Depends on the Situation.
Autoimmune treatments for vitiligo involve suppressing the immune response so the melanocytes can survive.
Topical treatments are generally the first line of therapy for vitiligo that is localized in a smaller area.
Oral systemic treatments are reserved for widespread vitiligo involving large areas of the body, and particularly if the vitiligo is rapidly progressing.
Considerations for Use of Topical Treatments:
Cannot prevent new areas of pigment loss from developing
Primarily for use with stable vitiligo
Generally prescribed for limited pigment loss:
Impractical for use over extensive body surface area
Time consuming: Must be applied twice daily for many months
Messy: Greasy residue can stain clothing, bedding, and furniture
Considerations for Use of Oral Systemic Treatments:
This is a rapidly evolving topic! Even as recently as 2 years ago, systemic treatments for vitiligo were somewhat controversial and difficult to obtain. In an effort to suppress the immune response to stop it from attacking and killing the melanocytes, systemic treatments of the past suppressed the body’s entire immune system.
Outside of any side effects of each specific treatment, the general problem with this approach has been the potential for side effects of weakening the overall immune system’s ability to do its job protecting the body, leaving users more susceptible to bacteria, germs, viruses, and infections.
A key benefit of JAKi’s is that they work by selectively targeting and blocking only the disease-specific immune cells rather than suppressing the entire immune system.
Narrowband UV-B Adds a Unique Factor
The authors of this study, led by Julien Seneschal, MD, PhD, Professor of Dermatology at Bordeaux University Hospital in Bordeaux, France, noted that limited case series involving oral JAKi’s, and a phase 2 trial with a topical JAKi, suggested that combining phototherapy with a JAKi appeared to enhance the treatment response. However, to their knowledge, this was the first double-blind phase 2 proof-of-concept, randomized clinical trial testing phototherapy being combined with a systemic oral JAKi.
How Did the Clinical Trial Work?
At the beginning of the trial, pigment loss for each participant was determined by using the Vitiligo Area Scoring Index (VASI), a clinical tool used to assess the affected body surface area and level of depigmentation. The higher the VASI score, the greater the percentage of pigment loss.
Participants were assigned to either receive the baricitinib 4mg tablet or an oral placebo once daily. For the first 12 weeks, participants received only the baricitinib or placebo, followed by 24 weeks of combining the daily oral therapy with twice-weekly NB UVB phototherapy.
This Combined Therapy is Considered a “One-Two Punch.”
By targeting and blocking the JAK pathway, baricitinib suppresses the A/I attack, reducing inflammation and stopping the attack on the melanocytes. This helps to rapidly stabilize the vitiligo, preventing further pigment loss.
Then NB-UVB stimulates melanocyte growth and repopulation. Once the immune attack is under control, NB-UVB helps restore pigmentation by enhancing melanin production, allowing melanocytes to produce new pigment and spread into the depigmented areas.
What Was the Outcome?
The Results Were Pretty Remarkable!
The Baricitinib/Phototherapy Group Achieved a 44.8% Reduction in VASI scores Compared to Only 9.2% in the Placebo/Phototherapy Group.
It would seem that as anticipated, the baricitinib group achieved a head start stabilizing the immune response, so that when NB-UVB was initiated, the conditions were already favorable for the melanocytes to begin repopulating.
In addition to increased repigmentation and a reduction of disease activity, participants in the baricitinib group also reported greater improvements in their quality of life.
Adverse Events
At this time, all JAKi’s, including baricitinib, carry boxed warnings about potential risks such as infections, cardiovascular events, and malignancies. However, in this clinical trial, the research team reported no unexpected safety concerns, and no significant distinction in adverse events between the baricitinib group and placebo group. They feel these results justify a larger phase 3 trial in the future.
What Can You Do If You
Can’t Afford the Treatment?
Q. Looking for a doctor who agreed there are treatments that work was so frustrating that I finally gave up a few years ago. Recently, when I started seeing commercials for a new treatment actually approved for vitiligo, my hopes were raised again!
I was so happy when I found a doctor willing to write a prescription for treatment, but then my insurance company refused to cover it. Even after my doctor wrote a letter of appeal and provided all the documentation requested, my claim was still denied.
Do you have any suggestions that might help
me get a treatment that I can afford?
A. As great as it is that we finally have an FDA-approved treatment for the repigmentation of vitiligo, the reality is, that for a variety of reasons, this medication and many others remains out of reach for many in our community.
Prescription treatments for vitiligo have long been notoriously expensive. When you add the barrier of the expense to the length of time that it takes for any vitiligo treatment to achieve a positive outcome, even for many of those who initially are able to obtain a prescription, it becomes cost-prohibitive to continue.
There are options such as the drug manufacturers’ “patient assistance” programs that can be helpful. However, the qualifying “Terms and Conditions” either leave many out to begin with or provide an insufficient amount of product to be helpful.
There is Good News!
Many medications that are prescribed for vitiligo, including some of the newer JAK inhibitors, are available from specialty compounding pharmacies, and many times, though not always, they are far less expensive than the commercially manufactured products.
These medications will still require a written prescription from your doctor. However, it seems that many physicians are either not aware of this option or do not have the contact information for a reputable compounding pharmacy that can ship out of state.
If you find that your insurance will not cover a medication that your health care provider has prescribed, it’s certainly worth the time to make a phone call to see if a compounded equivalent is available. In some instances, a compounded formulation could bring the cost down from over $2,000.00 to under $100.00!
Some of the medications regularly prescribed for vitiligo
that are available in compounded formulation:
Clobetasol Propionate
Coal tar
Hydrocortisone
Hydroquinone
Monobenzone
Ruxolitinib (JAK inhibitor)
Tacrolimus
Tofacitinib (JAK inhibitor)
VSI can provide contact information for a reputable compounding pharmacy that routinely makes and ships medications (only within United States, Puerto Rico, and Guam)
Research & Clinical Trials
TEV-53408 Treatment Study
Recruiting in 11 U.S. States
Now enrolling adults with Vitiligo to participate in a clinical trial
investigating TEV-53408 for the treatment of Vitiligo.
TEV-53408 is an antibody designed to target specific immune cells
from attacking the pigment-producing cells (melanocytes) in the skin
which are thought to play a key role in creating vitiligo patches.
Compensation for time and travel may be available.
Requirements:
- 18-75 years old
- You live in the United States
- You have non-segmental vitiligo (patches on both sides of the
body or face)
Why Join?
- Opportunity to access a potentially cutting-edge investigational
treatment - Receive expert study-related medical care at no cost
- Play a key role in making better treatments for Vitiligo
Currently Recruiting in the following U.S. States:
AZ, AR, CA, FL, IL, KY, MI, OR, TX, UT
Check Study Locations Below for Updated list
For Participation Criteria: Click Here.
For Recruiting Study Locations: Click Here.
For Additional Information: [email protected]
Pediatric Treatment Study
Recruiting in 92 Locations
in US and Canada
A Phase 3 Study to Evaluate the Safety and Efficacy
of JAK Inhibitor, Ruxolitinib Cream, in
Pediatric Participants with Nonsegmental Vitiligo.
The purpose of this study is to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo. Nonsegmental Vitiligo.
Ages Eligible: 2 Years to 11 Years
Additional Participation Criteria
Currently Recruiting in 92 Locations
Click Here for Complete List of Sites and Contacts
For Additional Information:
Contact: [email protected]
Afamelanotide Treatment Study
Recruiting in 30 Locations
DO YOU HAVE GENERALIZED VITILIGO
ON THE FACE AND BODY (for at least 3 months)?
Study Information:
An investigational therapy called afamelanotide is being
evaluated as a treatment for vitiligo patients with darker skin types.
TWO STUDY TREATMENT GROUPS:
A. Narrowband ultraviolet B (NB-UVB) in combination with afamelanotide
B. NB-UVB alone
You may qualify if you:
- Are aged 12 or more
- Have medium to dark skin
- Do not have extensive white hair in your vitiligo patches
- Do not have a history of melanoma, lentigo maligna or do not have any
malignant (cancerous) skin lesions - Do not have liver diseases
- Are not pregnant or breastfeeding
Participation involves:
- NB-UVB light treatment twice per week for 20 weeks (all participants)
- Receiving an implant of afamelanotide every 3 weeks for 20 weeks (50%
of participants)
Click Here to See Recruiting Study Locations
EMAIL FOR ADDITIONAL INFORMATION:
[email protected]
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