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

NCT03047733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-02-09

No results posted yet for this study

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.

Conditions

  • Dermatologic Disease
  • Vitiligo

Interventions

DEVICE

The XTRAC Excimer Laser System

Initial irradiation dose was 50 mJ/cm2 on face and 100 mJ/cm2 on trunk and extremities. If there had not been minimal asymptomatic erythema, energy level was escalated by 50 mJ/cm2.

DRUG

Topical tacrolimus 0.1% ointment

Application of topical tacrolimus 0.1% ointment on the both lesions once daily.

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • HEE YOUNG KANG, M.D., Ph.D. · Ajou University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-21
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047733 on ClinicalTrials.gov