Key Updates in the Treatment of Patients With Vitiligo

Introduction

Vitiligo is a chronic depigmentation disorder resulting from autoimmune reactions that destroy pigmentary melanocytes, turning the skin milky white.¹ The two major types, nonsegmental vitiligo (NSV) and segmental vitiligo (SV), are primarily distinguished by the speed and bodily symmetry of depigmentation.² NSV tends to progress slowly throughout a person’s life, with symmetrical pigment loss on both sides of the body.^2-4 In contrast, pigment loss from SV is typically rapid and, once the skin stops losing color, nonprogressive.^2-4

People with vitiligo often experience emotional distress, low self-esteem and depression.⁵ To mitigate these symptoms, patients may seek treatments to repigment the skin. However, medications take time to be effective, and new patches of depigmented skin can develop while a patient treats existing patches.⁵

This article will explore recent updates regarding vitiligo, focusing on disease state education, recently approved and investigational treatments and clinical advances that may expand options and improve outcomes for patients with vitiligo.

Vitiligo disease state overview

Epidemiology and patient burden

According to the results of a U.S.-based online survey with more than 40,000 participants, the point prevalence of vitiligo varies between 0.76%, based on clinician adjudication, and 1.38%, based on self-report.⁶ A similar global survey reported that U.S. prevalence is 1.4%, noting that global prevalence varies by geographic region.⁷ Vitiligo prevalence is approximately equal between males and females and relatively similar across racial groups.^6,8 NSV is more common than SV,⁶ although prevalence estimates of SV vary between 5% and 16% of cases.^9-11

The characteristic depigmented skin patches usually are not painful,^12,13 but the disease’s impact on patients’ mental health is substantial. For example, among patients with NSV, treating physicians reported that 46% were affected by the disease in their everyday life, 47% experienced emotional impact and 44% had low self-esteem.¹⁴ The patients reported social isolation (20%), depression (21%), anxiety (32%) and — infrequently — bullying or abuse (6%).¹⁴ Patients also regularly tried to cover or hide their vitiligo (53%). Among those who covered their lesions, 31% applied makeup to the face, spending an average of 57 minutes a day on application; 18% used makeup elsewhere, spending an average of 30 minutes per day.¹⁴ Consistently, physicians and patients reported higher rates of psychosocial impact if there was facial depigmentation.¹⁴ This included suicidal ideation measurements, which physicians noted in 9% of all patients and 13% with facial involvement.¹⁴

Pathophysiology

Overall, the pathophysiology of vitiligo is complex and multifactorial.⁹ The fundamental mechanism for both disease subtypes involves autoimmune reactions that destroy melanocytes, which are cells located at the junction of the epidermal and dermal layers making up the skin’s pigment.^1,9 Specifically, molecular and cellular stress signals activate autoimmune cytotoxic T lymphocytes (CTLs) to kill melanocytes.⁹ The multifaceted sources of these stress signals involve numerous effectors and regulatory mechanisms.⁹ A commonly agreed-upon theory unifies patients’ genetic susceptibility, intrinsic skin abnormalities and oxidative stress damage converging in a way that activates the immune system and leads to melanocyte death.¹⁵

Research over the years has implicated several specific mechanisms in vitiligo depigmentation. One of these, the JAK-STAT cell signaling pathway, is the target of ruxolitinib, the only FDA-approved medication indicated for the topical treatment of NSV in patients 12 years and older.¹⁶ NSV depigmentation involves stressed melanocytes and/or keratinocytes releasing inflammatory mediators and immune cell recruitment molecules that recruit CTLs to the skin, inducing melanocyte death.^17,18 Once in the skin, CTLs release interferon (IFN)-gamma, activating the JAK-STAT pathway and triggering more production and release of immune cell recruitment molecules and additional melanocyte death.¹⁹ Ruxolitinib is a topical JAK inhibitor (JAKi) that induces repigmentation by inhibiting the JAK-STAT pathway and limiting gene expression of downstream inflammatory mediators and immune cell recruitment molecules.¹⁶ Additional JAKis with alternative routes of administration are under clinical investigation and will be discussed in more detail below.²⁰

The pathophysiology of SV is less well understood than that of NSV. In addition to an autoimmune component, SV is thought to involve neuro­chemically-mediated melanocyte death.⁹

Treatment landscape

Overview of vitiligo treatment options

The overall treatment algorithm, whether for NSV or SV, ultimately depends on goals established through shared decision-making between patients and care providers. These goals should consider patient/provider expectations, prognosis, pros and cons, the disease’s impact on the patient, current disease activity and location of depigmented lesions.²¹ Repigmentation is a common goal regardless of vitiligo subtype, and the recommended treatments include topical corticosteroids, topical calcineurin inhibitors, JAKis, phototherapy and — sometimes — surgical techniques such as skin grafting.²¹ Frequently, combining treatments achieves better repigmentation.²¹

The oldest vitiligo treatment, phototherapy, dates back to the ancient Egyptians and heliotherapy, which involves exposure to sunlight.²² Phototherapy remains useful today but is typically combined with medical treatments.²¹ Although clinicians still recommend natural exposure to sunlight in some instances,²³ modern phototherapy tools include narrowband-ultraviolet B (NB-UVB) and excimer lamps or lasers, which allow for both whole-body and targeted delivery, depending on the extent of depigmentation, current state of progression and disease subtype.²³ Home phototherapy devices offer convenience over visits to phototherapy centers but can be expensive and difficult for patients to obtain.²³

After phototherapy, potent or very potent topical corticosteroids are recommended for patients with vitiligo seeking repigmentation.^21,24 Some of the earliest evidence for these drugs’ efficacy came from a placebo-controlled investigation of 0.1% betamethasone valerate or 0.05% clobetasol propionate. Both drugs were considered effective for inducing repigmentation, but just 3 in 10 participants treated with betamethasone and only 1 in 10 treated with clobetasol exhibited a treatment effect.²⁴ Results of a more recent clinical​ trial based in the United Kingdom showed that topical corticosteroids induce repigmentation in only about a quarter of people with vitiligo, even when combined with NB-UVB phototherapy for a duration of nine months.²⁵ Still, among patients who may benefit from topical corticosteroids, the treatment algorithm recommends once-daily application or an intermittent schedule if local side effects are a concern.²³ Adding NB-UVB phototherapy to topical corticosteroids is more effective to induce repigmentation than corticosteroids alone.^20,25

Arising from safety concerns over long-term topical corticosteroid use and updated understanding of the autoimmune pathophysiology of vitiligo, topical calcineurin inhibitors are now first-line treatments for adult and pediatric patients with vitiligo.²³ In this drug class, early case reports demonstrated the efficacy of tacrolimus (0.1%).²⁶ The most recent treatment algorithm recommends either tacrolimus or pimecrolimus.²¹ Differential choice of topical calcineurin inhibitors or topical corticosteroids remains challenging, because these therapies have similar efficacy.^23,27,28 As with corticosteroids, adding phototherapy to topical calcineurin inhibitors may produce better repigmentation.^23,29

In 2022, following two successful phase 3 clinical trials — TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573) — the FDA approved the topical JAKi ruxolitinib (1.5%) with an indication to treat NSV in patients 12 years and older.^16,30,31 To date, ruxolitinib remains the only medication with an approved indication for NSV. The aforementioned non-JAKi medications are all used off-label.⁹ More detail of the ruxolitinib clinical trials will be presented later. The treatment algorithm generally recommends phototherapy as a potential add-on therapy to daily ruxolitinib application. ^23,29

Ongoing phase 3 clinical trials are investigating the orally administered JAKis povorcitinib (STOP-V1, NCT06113445; STOP-V2, NCT06113471)^32,33 and ritlecitinib (Tranquillo, NCT05583526; Tranquillo 2, NCT06072183; Tranquillo LTE, NCT06163326).^34-36 Recently completed phase 2 clinical trials evaluated the oral JAKis baricitinib (BARVIT, NCT04822584)³⁷ and upadacitinib (NCT04927975).^20,38

Outcomes from recent clinical trials

Because the use of topical calcineurin inhibitors to repigment the skin of patients with vitiligo remains off-label and unlicensed,²³ one of these medications — tacrolimus — was the subject of a recent phase 3 multicenter, double-blinded, vehicle-controlled clinical trial (VITAC; NCT02466997).³⁹ Participants included adults with NSV with depigmented lesions on the face.³⁹ Twice daily, those in the treatment group applied tacrolimus (0.1%), and the control group applied a vehicle ointment; both groups could expose themselves to natural sunlight without sunscreen.³⁹ At the 24-week end point, 65% of participants using tacrolimus exhibited at least 75% improved repigmentation over baseline compared with none of the vehicle control group.³⁹ The most commonly reported side effects were flushing after alcohol consumption and burning at the application site, but these did not lead to discontinuing treatment. Many participants also reported that the texture of the tacrolimus ointment was unpleasant for daily skin care.³⁹

The FDA approval of ruxolitinib came after two successful phase 3 clinical trials.³¹ Trial data included a total of 674 patients 12 years and older with NSV and depigmented lesions covering 10% or less of total body surface area (BSA), with at least 0.5% facial depigmentation and at least 3% nonfacial depigmentation.³⁰ Participants were randomly assigned 2-to-1 to apply ruxolitinib or the vehicle control treatment twice daily to all depigmented lesions for 24 weeks, after which all participants were allowed to switch to ruxolitinib for a 28-week open-label extension.³⁰ Across both trials at the week 24 primary end point, 29.8% (TRuE-V1) and 30.9% (TRuE-V2) of participants in the ruxolitinib group exhibited at least a 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI75) compared with just 7.4% and 11.4% of participants in the vehicle group, respectively. After 52 weeks of ruxolitinib treatment, 52.6% (TRuE-V1) and 48.0% (TRuE-V2) exhibited an F-VASI75 response, as did 27% (TRuE-V1) and 30% (TRuE-V2) of participants initially treated with vehicle who switched over to ruxolitinib during the extension.³⁰ Side effects that occurred in 1% or more of participants included application-site acne, itching, nasopharyngitis, headache, urinary tract infection, application-site erythema and fever.¹⁶

Clinical and preclinical investigative advances for vitiligo treatment

Ongoing and recently completed clinical investigations demonstrate that developing new medical interventions for patients with vitiligo remains an active area of investigation.²⁰ Likewise, preclinical research may reveal novel agents and therapeutic targets that could amount to the next generation of medical interventions for vitiligo.⁴⁰

The approval of topical ruxolitinib was a major clinical advance for patients with vitiligo, but systemic oral therapies remain of therapeutic interest for their ease of administration. One of these, ritlecitinib, recently completed a multinational phase 2b randomized, double-blind, placebo-controlled, dose-ranging study to examine safety and efficacy in patients with NSV involving 4% to 50% BSA (NCT03715829).⁴¹ Participants received either placebo or ritlecitinib (10, 30 or 50 milligrams) for 24 weeks; in a subgroup analysis, some participants randomly assigned to the ritlecitinib arm were designated to take a loading dose (100 or 200 milligrams) for four weeks, followed by 20 weeks of maintenance dosing (50 milligrams).⁴¹ After 24 weeks of treatment, patients taking ritlecitinib (50 milligrams) with or without a loading dose demonstrated significant improvements to F-VASI from baseline (adjusted p-value, < 0.001), with some of these improvements evident as early as eight weeks.⁴¹ Specifically, 7.7% to 12.1% of participants taking at least 50 milligrams of ritlecitinib achieved F-VASI75, compared with none of the participants taking placebo.⁴¹ Side effects that emerged throughout treatment were usually mild (40.1%) or moderate (33%), including nasopharyngitis (15.9%), upper respiratory tract infection (11.5%) and headache (8.8%).⁴¹

Preclinical investigations may reveal novel drugs available for development beyond the drug classes suggested by the current vitiligo treatment algorithm. For example, a recent publication detailed the results of a mouse model of vitiligo in which the researchers gave Bacillus subtilis-derived exopolysaccharide to vitiligo-prone mice.⁴⁰ Overall, exopolysaccharide treatment slowed the mice’s depigmentationand reduced the production of IFN-gamma, a key inflammatory mediator of vitiligo depigmentation.⁴⁰ Together, these results demonstrate that new therapeutic interventions for vitiligo may come from unconventional sources.

Considerations regarding route of administration

Ruxolitinib is the only FDA-approved medication indicated for the topical treatment of NSV.¹⁶ Other vitiligo first-line treatments, such as corticosteroids and calcineurin inhibitors, are also topical.²² Meanwhile, investigational JAKis (ritlecitinib, upadacitinib, povorcitinib and baricitinib) are being developed as oral treatments.²⁰ Assuming at least one is eventually approved, clinical conversations will need to differentially consider therapeutic effects and drug safety based on route of administration.

The prescribing information for topical ruxolitinib names several side effects associated with oral JAKis that clinicians should be aware of before offering ruxolitinib to their patients. These include cholesterol changes, lymphoma and increased rates of opportunistic infections, cardiovascular events or mortality among patients 50 years and older who have at least one cardiovascular risk factor.¹⁶ Meanwhile, in the TRuE-V1 and TRuE-V2 trials, topical ruxolitinib was most commonly associated with application-site acne (5.9% and 5.7%, respectively) and pruritus (5.0% and 5.3%, respectively).³⁰ The prescribing information for topical ruxolitinib also warns of serious lower respiratory tract infections, reactivation of some herpes virus infections, nonmelanoma skin cancers, thromboembolic events and cytopenias (thrombocytopenia, anemia and neutropenia).¹⁶ The nonmelanoma skin cancers, thromboembolic events and cytopenias were all observed in a long-term safety study of topical ruxolitinib for atopic dermatitis and occurred in no more than 4% — and most less than 2% — of participants.⁴²

Cost and access considerations

Healthcare cost burden among patients with vitiligo

Patients with vitiligo tend to incur higher healthcare costs. A recent retrospective study of commercial healthcare database claims data found that patients with vitiligo paid $7,816 (in 2021 U.S. dollars) more in all-cause total healthcare costs and $3,436 more in vitiligo-related healthcare costs than matched patients without vitiligo.⁴³ The same study also revealed that patients with vitiligo were responsible for a greater proportion of healthcare resource use than matched patients without vitiligo; this included emergency room visits, inpatient visits, outpatient visits and mental health-related healthcare resource use.⁴³ Because of the effects of higher overall costs and greater healthcare resource use, clinical providers devising treatment plans have a responsibility to inform their patients with vitiligo of drug-related concerns and should address concerns related to the patients’ socioeconomic status.⁴⁴

Conclusion

Vitiligo is a chronic autoimmune depigmentation disorder that has a substantial psychosocial impact on patients.¹⁴ First-line treatments such as topical corticosteroids and calcineurin inhibitors are recommended by clinical experts, but many of these options exhibit limited efficacy for repigmentation,^23,27,28 and all are used off-label.⁹ Currently, ruxolitinib is the only FDA-approved medication indicated for the topical treatment of NSV in patients 12 years and older. ^16,31 Additional medications in the same drug class are being investigated as oral treatments for vitiligo, demonstrating the evolving treatment landscape.²⁰ Likewise, preclinical investigations into alternative treatment mechanisms, such as microbial therapy, may lead to a new class of available drugs.⁴⁰ As new treatments develop, clinical conversations will need to differentially consider therapeutic effects and drug safety based on route of administration. These discussions should also involve shared decision-making that considers therapeutic goals, patient/provider expectations, prognosis, impact of the disease on the patient, current disease activity and patient concerns about treatment cost and access.^21,44

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25. Thomas KS, Batchelor JM, Akram P, et al; UK Dermatology Clinical Trial Network’s HI-Light Vitiligo Trial Team. Randomized controlled trial of topical corticosteroid and home-based narrowband ultraviolet B for active and limited vitiligo: results of the HI-Light Vitiligo Trial. Br J Dermatol. 2021;184(5):828-839. doi:10.1111/bjd.19592

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29. Pandya AG, Harris JE, Lebwohl M, et al. Addition of narrow-band UVB phototherapy to ruxolitinib cream in patients with vitiligo. J Invest Dermatol. 2022;142(12):3352-3355.e4. doi:10.1016/j.jid.2022.05.1093

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31. Incyte announces U.S. FDA approval of Opzelura (ruxolitinib) cream for the treatment of vitiligo. News release. Incyte Corporation. July 18, 2022. Accessed June 12, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-us-fda-approval-opzeluratm-ruxolitinib-cream-0

32. A study to evaluate efficacy and safety of povorcitinib in participants with nonsegmental vitiligo (STOP-V1). ClinicalTrials.gov. Updated March 27, 2025. Accessed August 13, 2025. https://clinicaltrials.gov/study/NCT06113445

33. A study to evaluate efficacy and safety of povorcitinib in participants with nonsegmental vitiligo (STOP-V2). ClinicalTrials.gov. Updated March 20, 2025. Accessed August 13, 2025. https://clinicaltrials.gov/study/NCT06113471

34. A 52-week study of ritlecitinib oral capsules in adults and adolescents with nonsegmental vitiligo (active and stable) Tranquillo (Tranquillo). ClinicalTrials.gov. Updated July 11, 2025. Accessed August 13, 2025. https://clinicaltrials.gov/study/NCT05583526

35. A 104-week study of ritlecitinib oral capsules in adults with nonsegmental vitiligo (active and stable) Tranquillo 2 (Tranquillo 2). ClinicalTrials.gov. Updated June 13, 2025. Accessed August 13, 2025. https://clinicaltrials.gov/study/NCT06072183

36. A 52-week study to learn about the safety and effects of ritlecitinib in participants with nonsegmental vitiligo (Tranquillo LTE). ClinicalTrials.gov. Updated December 4, 2024. Accessed August 13, 2025. https://clinicaltrials.gov/study/NCT06163326

37. Evaluation of effect and tolerance of the association of baricitinib and phototherapy versus phototherapy in adults with progressive vitiligo (BARVIT). ClinicalTrials.gov. Updated June 13, 2023. Accessed August 13, 2025. https://clinicaltrials.gov/study/NCT04822584

38. Study to evaluate adverse events and change in disease activity with oral tablets of upadacitinib in adult participants with non-segmental vitiligo. ClinicalTrials.gov. Updated October 8, 2024. Accessed August 13, 2025. https://clinicaltrials.gov/study/NCT04927975

39. Seneschal J, Duplaine A, Maillard H, et al. Efficacy and safety of tacrolimus 0.1% for the treatment of facial vitiligo: a multicenter randomized, double-blind­ed, vehicle-controlled study. J Invest Dermatol. 2021;141(7):1728-1734. doi:10.1016/j.jid.2020.12.028

40. Touni AA, Muttar S, Siddiqui Z, et al. Bacillus subtilis-derived exopolysaccharide halts depigmentation and autoimmunity in vitiligo. J Invest Dermatol. Published online December 31, 2024. doi:10.1016/j.jid.2024.12.006

41. Ezzedine K, Peeva E, Yamaguchi Y, et al. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: a randomized phase 2b clinical trial. J Am Acad Dermatol. 2023;88(2):395-403. doi:10.1016/j.jaad.2022.11.005

42. Papp K, Szepietowski JC, Kircik L, et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies. J Am Acad Dermatol. 2023;88(5):1008-1016. doi:10.1016/j.jaad.2022.09.060

43. Ezzedine K, Soliman AM, Li C, Camp HS, Pandya AG. Economic burden among patients with vitiligo in the United States: a retrospective database claims study. J Invest Dermatol. 2024;144(3):540-546.e1. doi:10.1016/j.jid.2023.08.025

44. Iqbal A, Salman M. Do the benefits of Opzelura (ruxolitinib) outweigh the potential risks? An insight into the FDA-approved treatment for non-segmental vitiligo (NSV). Int J Surg Open. 2023;55:100630. doi:10.1016/j.ijso.2023.100630