OBJECTIVE: To compare the efficacy of conventional continuous excimer laser treatment and cyclic on-off scheduled excimer laser treatment in vitiligo.
DESIGN: A randomized, controlled, split-body, non-inferiority study.
SETTING: The trial was performed in two tertiary health care centers in Korea.
PARTICIPANTS: 12 patients (16 pairs of lesions) with bilateral and symmetrically distributed vitiligo and whose disease duration was less than 5 years. The patients taking systemic steroids or having enlarging lesions were excluded. All of 12 patients completed the study.
INTERVENSIONS: All lesions were treated twice weekly by excimer laser for a total of 9-month trial period: continuously in group A, or cyclically with 2-month treatment and 1-month intermission every 3 month (total 3 cycles during the trial) in group B. Topical tacrolimus 0.1% ointment was equally applied to both groups throughout the trial.
MAIN OUTCOMES AND MEASURES: Photographic documentation of lesions was conducted every month and the final degree of repigmentation of each group was assessed with a repigmentation rate (%) by using image analysis software. The non-inferiority margin was set at 10%.
RESULTS: The mean difference of repigmentation rate between group A and B was 2.194% and the 95% confidence interval (-4.982% to 9.370%) was lower than the non-inferiority margin (10%). In group B, neither loss of repigmentation nor worsening of the vitiligo lesions was observed during intermission.
CONCLUSIONS AND RELEVANCE: The cyclic on-off excimer laser treatment was as effective as the continuous excimer laser treatment in vitiligo. It can be a new treatment strategy for vitiligo without deteriorating the disease.