NB-UVB 311 nm vs PUVA in Vitiligo: Randomized Comparative Study (24 Weeks)

  • Primary endpoint: Mean % change in F-VASI at week 24 better with NB-UVB vs PUVA (−48.6% vs −39.2%; Δ −9.4 pp; p=0.031).
  • Face/neck response (≥50% repigmentation): 62% NB-UVB vs 46% PUVA.
  • Adverse events: less nausea and phototoxicity with NB-UVB; comparable erythema.

Abstract

Objective: Compare NB-UVB 311 nm and PUVA in non-segmental vitiligo over 24 weeks.

Design: Randomized, parallel-group, open-label with blinded assessors; multicenter (3 sites).

Participants: N=118 adults (NB-UVB n=59; PUVA n=59); disease duration median 4.2 years.

Primary endpoint: % change in Facial VASI (F-VASI) at week 24.

Methods

  • Inclusion: Non-segmental vitiligo, F-VASI ≥1.0, stable or active.
  • Treatment: NB-UVB 3×/week (dose-escalation per erythema); PUVA 2×/week (8-MOP 0.6 mg/kg).
  • Assessments: F-VASI, T-VASI, PGA, photo-documentation (week 0, 8, 16, 24).
  • Stats: MMRM; missing data via multiple imputation; alpha=0.05 (two-sided).

Table 1. Study design and protocol parameters.
Parameter NB-UVB 311 nm PUVA
Frequency 3× per week 2× per week
Starting dose 200 mJ/cm² 8-MOP 0.6 mg/kg + UVA
Dose escalation +10–20% if no erythema +0.5–1 J/cm² per tolerance
Max dose 1,200 mJ/cm² Up to 12 J/cm²
Duration 24 weeks

Results

Table 2. Efficacy outcomes at week 24 (mITT population).
Outcome NB-UVB (n=59) PUVA (n=59) Between-group Δ (95% CI) p-value
F-VASI % change (↓ better) −48.6% −39.2% −9.4 pp (−18.0, −0.9) 0.031
T-VASI % change −31.7% −25.5% −6.2 pp (−12.9, +0.5) 0.070
≥50% repigmentation (face/neck) 62% 46% RR 1.35 (1.02–1.78) 0.036

Sensitivity analyses (per-protocol, tipping-point) confirmed robustness of the primary endpoint.

Safety

Table 3. Adverse events (≥5% of patients).
Event NB-UVB PUVA
Erythema (mild/moderate) 28% 26%
Nausea 2% 17%
Phototoxic reaction 0% 7%

Subgroup Analyses

  • Disease activity: benefit of NB-UVB consistent in stable and active subsets (interaction p=0.41).
  • Phototype: greater absolute F-VASI reductions in III–IV vs I–II; no treatment×phototype interaction.

Limitations

Open-label design (with blinded assessors), 24-week duration, no maintenance phase, and center-level heterogeneity may limit generalizability.

Conclusion

NB-UVB 311 nm provided superior facial repigmentation at 24 weeks versus PUVA with a more favorable tolerability profile. Findings support NB-UVB as first-line phototherapy in non-segmental vitiligo.

References

  1. Njoo MD, et al. Narrowband UVB phototherapy in vitiligo… Arch Dermatol. 1998.
  2. Hamzavi I, Lim HW, et al. Current and emerging treatments… Dermatol Clin. 2020.
  3. Ezzedine K, Lim HW, et al. Consensus classification… Pigment Cell Melanoma Res. 2015.

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