Summary
Tacrolimus has reached Phase III as its most advanced recorded development stage across any indication, and the database holds no approval for Vitiligo. ClinicalTrials.gov lists 8 registered trials linking Tacrolimus to Vitiligo: 1 is currently recruiting; 1 is active or not yet recruiting; 2 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03199664). It plans or enrolled 100 participants. Registration activity spans 2011 to 2025. The literature layer holds 11 publications for this pair: 5 Cochrane reviews, 1 systematic review and 5 clinical trial publications. Publication years run from 2024 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Vitiligo ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous complete repigmentation extremely rare (<1%); partial spontaneous repigmentation possible in small lesions; progressive without treatment in most patients.
Evidence table
| Evidence tier | B · Moderate |
|---|---|
| Evidence score | 56.5 (trials 16.5, literature 30.0, tier 10, approved bonus 0.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 2 completed, 4 other |
| Linked publications | 11 (5 Cochrane reviews, 5 clinical trial publications, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Phase III |
| Mechanism / class | Not recorded |
| Data sources | Open Targets |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT03199664 | Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo 2017 | status unknown | Phase 4 | 100 |
| NCT07532330 | Tyrosine Vs Tacrolimus With NB-UVB in Vitiligo 2025 | active, not recruiting | Not applicable | 67 |
| NCT05706636 | T Central Memory Cells in Early Localized Non-Segmental Vitiligo 2023 | completed | Not applicable | 22 |
| NCT03047733 | Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo 2015 | completed | Not applicable | 12 |
| NCT06719024 | Topical Ruxolitinib for Face and Neck Vitiligo of Adult Chinese Patients Refractory to Topical Tacrolimus 2024 | recruiting | PHASE2, PHASE3 | 20 |
| NCT01841008 | Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control 2011 | terminated | PHASE2, PHASE3 | 35 |
| NCT03365141 | Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo 2017 | status unknown | Not applicable | 12 |
| NCT04765826 | Comparison Between Systemic Steroids, Topical Steroids, or Calcineurin Inhibitors With Mini Punch Grafting in Treatment of Stable Non-segmental Vitiligo 2021 | status unknown | Not applicable | 60 |
Published literature
- Clinical trial publication Efficacy of oral JAK inhibitors combined with 308-nm excimer laser in pediatric progressive vitiligo: A multicenter studyChang S, Zhang L, Liu B et al. · Journal of the American Academy of Dermatology · 2026 · PMID 41780599
- Cochrane review Shining Light on Treatments: A Systematic Review of Existing Therapies for Pediatric Segmental VitiligoGhani H, Hoffman V, Shah A et al. · Pediatric dermatology · 2026 · PMID 41936454
- Clinical trial publication Comparative efficacy of topical tofacitinib versus topical tacrolimus in the treatment of localized vitiligo: a randomized investigator-blinded intraindividual trialMehta H, Bishnoi A, Vinay K et al. · The British journal of dermatology · 2025 · PMID 40758816
- Clinical trial publication Efficacy of topical tacrolimus 0.03% ointment in combination with microneedling versus topical phenytoin 2% cream in combination with microneedling for the treatment of non-segmental facial vitiligoAbdelaziz RK, Mohammed HAK, Fouda I · Archives of dermatological research · 2025 · PMID 40185951
- Clinical trial publication [Effect of needle cauterization on vitiligo with deficiency cold and blood stasis: a randomized controlled trial]DU H, Liu X, Wu B et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2025 · PMID 40097215
- Cochrane review Microneedling for Non-cosmetic Dermatologic Conditions: A Systematic Review of Efficacy and SafetyMashi A, Oraybi RA, Hakami MS et al. · Cureus · 2025 · PMID 40995236
- Cochrane review The efficacy and safety of microneedling combined with tacrolimus versus tacrolimus monotherapy for vitiligo treatment: a systematic review and meta-analysisMaaddawi HA, Aljuaid AA, Alamri AM et al. · Dermatology reports · 2025 · PMID 39992062
- Cochrane review The Microneedle Revolution: Transforming Vitiligo Treatment Landscapes-A Comprehensive Review of the LiteratureAlshiyab D, Ba-Shammakh SA, Haj-Freej HM et al. · Journal of cutaneous medicine and surgery · 2025 · PMID 39425450
- Clinical trial publication Efficacy and safety of fire needle therapy in treating non-segmental stable vitiligo: A randomized self-controlled clinical trialWang Y, Lin M, Huang F et al. · Journal of cosmetic dermatology · 2024 · PMID 38894565
- Cochrane review 308 nm excimer laser and tacrolimus ointment in the treatment of facial vitiligo: a systematic review and meta-analysisSuo DF, Zeng SW, Meng LH · Lasers in medical science · 2024 · PMID 38456924
- Systematic review Utility of prostaglandin analogues and phosphodiesterase inhibitors as promising last resorts for the treatment of vitiligo: A systematic review, from mechanisms of action to mono-, combination and comparative therapiesPourriyahi H, Hosseini NS, Nooshabadi MP et al. · Journal of cosmetic dermatology · 2024 · PMID 39158214
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is B (Moderate), derived from the strength of the disease association recorded in Open Targets. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Tacrolimus approved for Vitiligo?
Tacrolimus has reached Phase III as its most advanced recorded development stage across any indication, and the database holds no approval for Vitiligo. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tacrolimus in clinical trials for Vitiligo?
ClinicalTrials.gov lists 8 registered trials linking Tacrolimus to Vitiligo: 1 is currently recruiting; 1 is active or not yet recruiting; 2 have completed; 4 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03199664). It plans or enrolled 100 participants. Registration activity spans 2011 to 2025.
What does the evidence show for Tacrolimus in Vitiligo?
Tacrolimus has both completed registered trials and synthesis-level publications linked to Vitiligo. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is B (Moderate), derived from the strength of the disease association recorded in Open Targets. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.