The Effectiveness and Safety of Oral N-Acetylcysteine in Combination With Narrow-Band Ultraviolet B (NB-UVB) Phototherapy Compared With NB-UVB Phototherapy Alone in the Treatment of Vitiligo: A Pilot Study.

BACKGROUND AND AIMS: Vitiligo is an autoimmune skin disease, characterized by depigmented patches over skin. Numerous studies have been conducted to identify the most effective treatment for this condition. Based on high rate of oxidative stress in pathogenesis of vitiligo, antioxidant treatments like N-acetylcysteine (NAC) is suggested. This study aimed to evaluate the efficacy and safety of oral NAC in combination with narrow-band UVB (NB-UVB) phototherapy, comparing it to NB-UVB therapy alone in treating patients with generalized vitiligo.

METHODS

This single-blind, randomized controlled Phase 1 trial conducted over a period of 4 months, involving 16 participants. The patients were split into two, with one group receiving 600 mg of oral NAC twice daily, alongside NB-UVB, while the control group received only phototherapy. The patients were reassessed after 2 and 4 months, with evaluations based on the Vitiligo Extent Tensity Index (VETI), overall patient satisfaction, treatment tolerability, and side effects.

RESULTS

Among the 16 patients, 68.8% were male, with an average age of 40.7 ± 9.9 years. Both treatment groups showed a significant reduction in VETI scores during the second and third assessments (p < 0.05). However, the difference between the two groups was not statistically significant (p > 0.05). Patient satisfaction was notably higher in the NAC + NB-UVB group during the second visit (p = 0.01), and by the third visit, 75% of patients in the NAC + NB-UVB group reported excellent satisfaction, compared to 25% in the control group (p = 0.07). Treatment tolerability was similar across both groups, though one patient in the NAC + NB-UVB group experienced dizziness, which was resolved after adjusting the dose.

CONCLUSION

Oral NAC appears to be a safe adjuvant therapy in the treatment of generalized vitiligo patients in combination with NB-UVB phototherapy.

TRIAL REGISTER NAME: "Evaluation of the efficacy of NB-UVB phototherapy with oral N- acetylcysteine compared with NB-UVB phototherapy alone in the treatment of vitiligo patients: a randomized controlled clinical trial".Clinical trial registration number: IRCT20210729052013N1.