Vitiligo topical treatments
Only one of these five topical medicines is approved for vitiligo; the other four are borrowed off-label from other conditions.
Five evidence guides
Choose a topical to explore
US-approved vitiligo use
Opzeluraruxolitinib cream
Cream · 1.5%
FDA-approved in the US for nonsegmental vitiligo in adults and children age 12 and older. Checked 7 August 2026.
European Union: the European Medicines Agency record shows a marketing authorisation dated 19 April 2023, held by Incyte Biosciences Distribution B.V. It covers non segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. That authorised population is narrower than the US one because it requires facial involvement. Checked 17 August 2026. Great Britain: not established in the records I reviewed. An authorisation in one jurisdiction is not an approval in another.
Why you may be hereYou may be checking the US-approved vitiligo option against its age, diagnosis, warning, and access boundaries.
Read the Opzelura evidence guideOff-label vitiligo use
Protopictacrolimus ointment
Ointment · 0.03% and 0.1%
Used off-label for vitiligo in the US. Its FDA-approved indication is atopic dermatitis, not vitiligo.
Why you may be hereYou may have been offered tacrolimus and want to understand off-label use, the ointment form, and the boxed-warning context.
Read the Protopic evidence guideOff-label vitiligo use
Elidelpimecrolimus cream
Cream · 1%
Used off-label for vitiligo in the US. Its FDA-approved indication is atopic dermatitis, not vitiligo.
Why you may be hereYou may be comparing this cream with tacrolimus and need to see where its product-specific vitiligo evidence is more limited.
Read the Elidel evidence guideOff-label vitiligo use
Topical corticosteroidsmometasone, clobetasol, betamethasone and others
Multiple products and forms · the exact ingredient matters
Common guideline-backed, off-label vitiligo treatment in the US. The exact product and potency matter.
Why you may be hereYou may have been prescribed a “steroid cream” and need to identify the exact product, potency, body-site limits, and risks.
Read the Topical corticosteroids evidence guideLower-confidence · off-label
Calcipotrienecalcipotriol · vitamin D analog
Cream · 0.005%
FDA-approved for psoriasis, not vitiligo. Sometimes discussed off-label as an add-on, but current vitiligo evidence is limited and inconsistent.
Why you may be hereYou may have heard of this psoriasis medicine as an add-on and want to understand why its vitiligo evidence is lower-confidence.
Read the Calcipotriene evidence guideThis directory does not recommend a treatment. A qualified clinician must confirm the diagnosis, exact product, body area, warnings, and whether an option fits you.
What does this directory distinguish?
Opzelura (ruxolitinib cream) is approved in the US for nonsegmental vitiligo. Protopic or generic tacrolimus, Elidel or generic pimecrolimus, and topical steroids are used off-label for vitiligo. Calcipotriene is also off-label. It is marked lower-confidence because the evidence for vitiligo is limited and mixed. Cards show regulator-labeled forms and strengths but do not give a use plan. Evidence Evidence Evidence Evidence Evidence Evidence Evidence
Why this matters
- Sources cited, not yet graded
The linked US labels show approved uses, forms, strengths, and warnings. Opzelura also has its own EU approval, dated 19 April 2023, for vitiligo that affects the face. The vitiligo guideline gives context for off-label topical use and calcipotriene’s weaker footing.
Considerations
- Depends on you
Directory status does not show whether a drug fits you, will help you, is safe for you, or is easy to get. Labels and evidence can change after the review date.
Questions for your next conversation
Which exact product and goal are we considering?
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Evidence behind this page
Sources
Each evidence badge opens the source and its limits. The full list stays available here.
- DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent efficacy evidence.
What this source supports
Supports the approved indication and product-specific local and systemic corticosteroid warnings for this ointment.
What it does not support
It is one current US product label, not a vitiligo indication, a class-wide substitute for every corticosteroid label or independent evidence of vitiligo benefit. Its Dosage and Administration section supports discontinuing once control is achieved and reassessing the diagnosis if no improvement is seen within 2 weeks; its Patient Counseling section notes pediatric safety and effectiveness beyond 3 weeks of use is not known. It is one currently marketed product listed under its generic chemical name, not a brand-name label.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
Protopic (tacrolimus) ointment: US prescribing information and Medication Guide (opens in a new tab)
DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent efficacy evidence.
What this source supports
It establishes the US atopic-dermatitis indication, boxed warning, local effects, long-term-use precaution, and ultraviolet instructions for this product. Its mechanism-of-action section supports that tacrolimus binds FKBP-12 to block calcineurin phosphatase, preventing the T-cell activation that its boxed warning and local-effect data describe. Its local-adverse-reaction data supports burning in roughly 46-58% and itching in roughly 41-46% of studied patients, most often in the first few days and easing as treatment continues. Its Dosage and Administration section supports applying a thin layer twice daily and re-examining the patient if signs and symptoms do not improve within six weeks.
What it does not support
It does not approve tacrolimus for vitiligo or psoriasis, establish efficacy for either, or resolve off-label guideline discussion of supervised combinations. Its dosing and six-week re-examination window are stated for its approved atopic-dermatitis indication, not as a vitiligo-specific schedule.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent efficacy evidence.
What this source supports
Supports the US atopic-dermatitis indication, boxed warning, application-site effects, long-term-use precaution and instructions to avoid ultraviolet treatment and minimize natural or artificial sunlight. This label itself is a generic pimecrolimus cream filing (packager Oceanside Pharmaceuticals, a division of Bausch Health US, LLC), not the original brand Elidel label, so it also supports that a generic pimecrolimus cream is currently marketed. Its Dosage and Administration section supports applying a thin layer twice daily and re-examining the patient if signs and symptoms persist beyond six weeks; its boxed warning separately supports that continuous long-term use should be avoided. Its adult 1-year active-comparator adverse-reaction table (328 pimecrolimus-treated subjects) supports application-site burning in about 25.9%, headache in about 25.4%, nasopharyngitis in about 7.6%, and influenza in about 9.8% of that adult trial population.
What it does not support
It does not approve pimecrolimus for vitiligo or psoriasis, establish efficacy for either, or resolve off-label guideline discussion of supervised combinations. Its dosing and six-week re-examination window, and its adult adverse-reaction percentages, are stated for its approved atopic-dermatitis indication and trial population, not as a vitiligo-specific schedule or vitiligo-trial safety rate.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Relevant relationship disclosed
- Published
- SteadySkin last checked
What this source can and cannot tell you
Why the independence label says this: The National Library of Medicine hosts DailyMed. The product company submits the label to FDA, so it is authoritative for product labeling but not independent vitiligo evidence.
What this source supports
Supports the psoriasis indication, 0.005% cream strength, current tube presentations, local irritation and dermatitis reports, the instruction not to use the cream on the face, contraindications for hypercalcemia or vitamin D toxicity, and calcium-related and ultraviolet precautions. Its Dosage and Administration section supports applying a thin layer twice daily, and that the label’s own safety and efficacy data cover an 8-week psoriasis treatment period. It supports that the label advises patients to avoid excessive natural or artificial sunlight and separately tells physicians they may wish to limit or avoid phototherapy in patients using this product. Its clinical-trial adverse-reaction data support skin irritation in about 10%-15% of patients (the most frequent reaction) and rash, itching, dermatitis, or worsening of psoriasis in about 1%-10%; post-approval reports separately support contact dermatitis, including allergic contact dermatitis.
What it does not support
It does not approve calcipotriene for vitiligo, establish vitiligo benefit, support a self-directed combination, or state a vitiligo-specific frequency, duration, or adverse-reaction rate. Its 8-week duration and adverse-reaction percentages are from psoriasis clinical trials, not a vitiligo population.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- European Medicines AgencyRegulatory · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports the European Union marketing authorisation dated 19 April 2023, the marketing authorisation holder Incyte Biosciences Distribution B.V., and the authorised EU indication wording: “Opzelura is indicated for the treatment of non segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.” It also supports that the authorised EU population is narrower than the US one because it requires facial involvement.
What it does not support
It does not establish the separate US indication, Great Britain or MHRA status, national pricing, reimbursement or pharmacy availability, comparative superiority, individual suitability, or any use plan.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- DailyMed, U.S. National Library of MedicineRegulatory · Regulatory / guideline, tier 1Independence not established
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports the defined US nonsegmental-vitiligo indication, limitations of use, boxed warnings, skin-cancer and ultraviolet precautions, and clinical-study labeling.
What it does not support
It also supports the labeled dosing instruction: "Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 10% body surface area." It further supports the labeled re-evaluation point: "If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re-evaluated by the healthcare provider." It also supports the vitiligo-trial adverse-reaction rates at 1% incidence or greater: application-site acne 6%, application-site itching 5%, a common-cold-type illness (nasopharyngitis) 4%, headache 4%, urinary tract infection 2%, application-site redness (erythema) 2%, and fever (pyrexia) 1%. It does not guarantee benefit, establish suitability beyond the labeled population, authorize adding phototherapy, or state which reaction should prompt a call to the prescriber beyond directing patients to the Medication Guide and their healthcare provider.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.
- British Journal of Dermatology (Eleftheriadou V, et al.)Guideline · Regulatory / guideline, tier 1Independent source
- Published
- SteadySkin last checked
What this source can and cannot tell you
What this source supports
Supports the clinical history and assessment domains, evaluation of associated autoimmune conditions, its recommendation for thyroid function and antithyroid antibody screening, current classification context, treatment-option map, psychosocial assessment, medical photography and the limits of pediatric evidence. Its classification table defines mucosal vitiligo as the oral or genital mucosae. One mucosal site alone is filed as undetermined or unclassified. Its differential diagnosis table lists genital or extragenital lichen sclerosus among the conditions that can be mistaken for vitiligo. That table also lists eczema, psoriasis, lichen planus, pityriasis alba and piebaldism. It calls autoimmunity a contributor to the pathogenesis of vitiligo. It reports an earlier review finding a possible negative impact on intimacy and sexual functioning. It tells clinicians to discuss the psychosocial impact of living with the condition. R28 offers a skin camouflage visit to people who want one. R10 to R14 name potent or very potent topical steroids as the first choice, with a topical calcineurin-inhibitor cream as an option for the face. These are different creams with different proof behind them. R20 names narrowband UVB as the first light option. It says the skin often does better on the face and trunk than on hands and feet. It says there is not enough proof to use any one current pill alone for vitiligo that is not changing. R25 and Table 2 keep cell grafting for vitiligo that is not changing and did not respond to other care. They also say a doctor cannot always tell if the vitiligo has truly stopped changing.
What it does not support
It was designed for UK care and reviewed literature through May 2019; it does not establish a universal testing plan, prescribe an individual plan, or establish current US labeling or coverage. Its differential diagnosis table is a list, not a method a reader can apply to their own skin. It does not say how to tell any two of those conditions apart. It gives no figure for how often vitiligo affects genital skin.
Claim-specific review for this source is still in progress. Only the source-level evidence and limits are shown here.