NB-UVB + Tacrolimus vs NB-UVB Alone in Vitiligo: Randomized Controlled Trial

Key Takeaways

  • Adding topical tacrolimus to NB-UVB is associated with higher facial response rates and earlier perifollicular repigmentation in many trials.
  • Safety is generally favorable; combination increases local irritation/erythema but avoids psoralen-related effects.
  • Greatest absolute gains seen on face/neck; acral sites remain challenging.

Abstract

This article summarizes randomized controlled data comparing NB-UVB plus topical tacrolimus versus NB-UVB alone in nonsegmental vitiligo. We outline design elements, dosing protocols, efficacy on facial and total VASI endpoints, safety profiles, and subgroup trends relevant to clinical decision-making.

Trial Design

Table 1. Study design and conduct.
Parameter NB-UVB + Tacrolimus NB-UVB Alone
Design Randomized, parallel-group; assessor-blinded photography
Duration 24–26 weeks treatment; 12–24 weeks follow-up
Centers Dermatology phototherapy clinics (multicenter)
Randomization 1:1 with site stratification
Concomitants Emollients allowed; no other immunomodulators

Participants

Table 2. Key inclusion/exclusion and baseline features.
Category Criteria
Inclusion Age ≥12; nonsegmental vitiligo; F-VASI ≥1.0 or T-VASI ≥3.0; stable or active
Exclusion Excessive sun exposure; recent systemic immunosuppressants; photosensitivity disorders
Baseline notes Phototypes II–V; facial involvement frequent; acral areas in subset

Interventions & Dosing

Table 3. Regimens.
Arm NB-UVB regimen Tacrolimus Notes
Combination 2–3×/week; start 200–300 mJ/cm²; +10–20% per session to mild erythema 0.1% ointment, thin layer BID on target lesions (esp. face/neck) Hold tacrolimus on treatment day in sensitive skin if irritation
Monotherapy Same NB-UVB schedule and escalation Emollients as needed

Endpoints

  • Primary: Change in F-VASI at week 24 or proportion achieving F-VASI50.
  • Secondary: T-VASI change; time to first visible repigmentation; patient/physician global assessment; durability at follow-up.
  • Exploratory: Perifollicular island count; lesion border softening; QoL change (DLQI or VitiQoL).

Results

Table 4. Efficacy outcomes (illustrative structure; populate with study data).
Outcome NB-UVB + Tacrolimus NB-UVB Alone Between-group
F-VASI % change (week 24) Greater reduction Reduction Favours combination
F-VASI50 responders Higher proportion Lower proportion Favours combination
T-VASI % change Meaningful reduction Meaningful reduction Difference varies by site
Time to visible response Earlier Later Favours combination
Durability (post-stop) Good with maintenance Good with maintenance Comparable

Safety

Table 5. Treatment-emergent adverse events (≥5%).
Event NB-UVB + Tacrolimus NB-UVB Alone Comments
Erythema Common, transient Common, transient Manage by dose hold/reduction
Burning/tingling at application site More frequent Less frequent Usually mild; improve with spacing applications
Pruritus/dryness Occasional Occasional Emollients; short topical steroid if needed

Subgroup Findings

  • Face/neck: largest absolute improvement with combination.
  • Acral: limited benefit in both arms; consider surgical options if stable.
  • Phototype: higher cosmetic gains in III–V; dosing must be individualized.
  • Early responders: week 4–8 perifollicular islands predict stronger endpoints.

Limitations

Heterogeneity in tacrolimus potency/frequency, NB-UVB dose algorithms, and endpoint definitions limits pooling; follow-up beyond 6–12 months is sparse.

References

  1. Randomized and comparative studies of NB-UVB plus topical tacrolimus versus NB-UVB alone in vitiligo.
  2. Phototherapy protocols for NB-UVB in vitiligo and guidance on topical calcineurin inhibitor use.
  3. Reviews on facial repigmentation strategies and maintenance approaches.

Leave a Comment

Your email address will not be published. Required fields are marked *

Shopping Cart
Scroll to Top