Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo

January 18, 2018 updated by: Jung Min Bae, The Catholic University of Korea
A randomized controlled non-inferiority trial based on split-body was planned to compare the efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The 308-nm excimer laser (EL) has been widely used for localized vitiligo. Recently, the 311-nm Ti:Sapphire laser (TSL) was developed to treat patients with vitiligo. To compare the efficacy of TSL vs. EL in the treatment of vitiligo.

A randomized controlled non-inferiority trial based on split-body was planned. The paired symmetric vitiliginous lesions will be randomized to either TSL or EL treatment groups. All lesions will be treated twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks, and the non-inferiority margin was set at 10%. Overall 16 patients will be enrolled.

Study Type

Interventional

Enrollment (Anticipated)

16

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 Contact

  • Name: Jung Min Bae, MD, PhD
  • Phone Number: 8209 82-31-249-8209
  • Email: jminbae@gmail.com

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16247
        • Recruiting
        • St. Vincent's 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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: older than 19
  • A patient with stable non-segmental vitiligo
  • A patient with symmetrical vitiligo lesions
  • A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
  • A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages

Exclusion Criteria:

  • Age: lower than 20
  • A pregnant or lactating patient
  • A patient with active or spreading vitiligo
  • A patient who cannot understand the study or who does not sign the informed consent

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
EXPERIMENTAL: The 311-nm Ti:Sapphire laser treatment group
All lesions were treated twice weekly for a total of 12-week period.
Device: 311-nm Ti:Sapphire laser
Pallas, LaserOptek, South Korea
ACTIVE_COMPARATOR: The 308-nm excimer laser treatment group
All lesions were treated twice weekly for a total of 12-week period.
Device: 308-nm excimer laser
XTRAC, PhotoMedex, US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The repigmentation rate (change from baseline) of the vitiliginous patch
Time Frame: Baseline and 12 weeks
The degree of repigmentation will be assessed as % from baseline by using a computer program.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The adverse effects of both two laser treatments
Time Frame: At 4 weeks, 8 weeks, and 12 weeks
At 4 weeks, 8 weeks, and 12 weeks

Collaborators and Investigators

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

Sponsor

The Catholic University of Korea

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

August 1, 2016

Primary Completion (ANTICIPATED)

January 30, 2018

Study Completion (ANTICIPATED)

August 30, 2018

Study Registration Dates

First Submitted

October 3, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (ESTIMATE)

October 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC16DISI0088

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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