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

February 7, 2017 updated by: Jae Min Sung, Ajou University School of Medicine

Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

[Study design and population] A randomized, controlled, split-body, non-inferiority trial was designed.

After obtaining informed consent, 12 patients with stable symmetric vitiligo less than 5 years' disease duration were enrolled.

The patients taking systemic steroids or having enlarging lesions were excluded. The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic excimer laser treatment.

Total duration of study was 9 months.

In cyclic excimer laser treatment, the cycle was arbitrarily determined that one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off) (total 3 cycles during the trial).

[Treatment protocol]

The lesions were treated twice a week. 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. In cyclic treatment, the treatment resumed after intermission with the previously used irradiation dose.

Topical tacrolimus 0.1% ointment was applied in both twice daily throughout whole length of the trial.

[Assessment and primary outcome] Photographic documentation of lesions was conducted every month and the degree of repigmentation was assessed with a repigmentation rate (%) from the baseline by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea).

An intention-to-treat analysis was planned, and last observation carried forward method was applied to impute the missing value in the presence of dropouts.

The primary outcome was mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment. The non-inferiority margin was set at 10%. During intermission period in the cyclic treatment, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.

[Statistical analysis] All statistical analyses were conducted using R 3.2.4 (R Foundation for Statistical Computing, Austria) and a P value <0.05 was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symmetric vitiligo
  • Patients with less than 5 years' disease duration

Exclusion Criteria:

  • The patients taking systemic steroids
  • The patients with currently enlarging lesions
  • The patients who cannot follow the treatment schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: continuously excimer laser treatment

In this group, lesions treated twice weekly through out the whole trial length (9 months).

Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).
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.
Other Names:
  • XTRAC Velocity 400
Drug: Topical tacrolimus 0.1% ointment
Application of topical tacrolimus 0.1% ointment on the both lesions once daily.
EXPERIMENTAL: cyclic excimer laser treatment

In this group, one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off).

Total 3 cycles of cyclic treatment through out the whole trial length (9 months). During the treatment period, lesions treated twice weekly.

Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).
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.
Other Names:
  • XTRAC Velocity 400
Drug: Topical tacrolimus 0.1% ointment
Application of topical tacrolimus 0.1% ointment on the both lesions once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment.
Time Frame: Through study completion, an average of 9 months
The degree of repigmentation was assessed with a repigmentation rate (%) with clinical photographs by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea).
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Study Director: HEE YOUNG KANG, M.D., Ph.D., Ajou University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 21, 2015

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (ESTIMATE)

February 9, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-DE3-15-151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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