drugset / Trial / NCT03047733

Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo

NCT03047733

Completed 12 enrolled Ajou University School of Medicine
RandomizedParallel-groupSingle-blindTreatment

Summary

OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the conventional continuous excimer laser treatment. DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was performed in two tertiary health care centers in Korea. PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5 years' disease duration were enrolled. INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles). Topical tacrolimus was applied throughout the trial. OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with clinical photographs. The primary outcome was mean difference of repigmentation rates and the non-inferiority margin was set at 10%. During intermission period, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.

Timeline

Start
2015-07-21
Primary completion
2016-12-31
Completion
2016-12-31

Drugs

EvaluationDrugModalityDoseRoute
Background Tacrolimus Small molecule 0.1 % Topical

Indications