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

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
311-nm Ti:Sapphire laser
308-nm excimer laser
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Vincent's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The 311-nm Ti:Sapphire laser treatment group

The 308-nm excimer laser treatment group

Arm Description

All lesions were treated twice weekly for a total of 12-week period.

All lesions were treated twice weekly for a total of 12-week period.

Outcomes

Primary Outcome Measures

The repigmentation rate (change from baseline) of the vitiliginous patch
The degree of repigmentation will be assessed as % from baseline by using a computer program.

Secondary Outcome Measures

The adverse effects of both two laser treatments

Full Information

First Posted
October 3, 2016
Last Updated
January 18, 2018
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02925767
Brief Title
Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
Official Title
Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
January 30, 2018 (Anticipated)
Study Completion Date
August 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The 311-nm Ti:Sapphire laser treatment group
Arm Type
Experimental
Arm Description
All lesions were treated twice weekly for a total of 12-week period.
Arm Title
The 308-nm excimer laser treatment group
Arm Type
Active Comparator
Arm Description
All lesions were treated twice weekly for a total of 12-week period.
Intervention Type
Device
Intervention Name(s)
311-nm Ti:Sapphire laser
Intervention Description
Pallas, LaserOptek, South Korea
Intervention Type
Device
Intervention Name(s)
308-nm excimer laser
Intervention Description
XTRAC, PhotoMedex, US
Primary Outcome Measure Information:
Title
The repigmentation rate (change from baseline) of the vitiliginous patch
Description
The degree of repigmentation will be assessed as % from baseline by using a computer program.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
The adverse effects of both two laser treatments
Time Frame
At 4 weeks, 8 weeks, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Min Bae, MD, PhD
Phone
82-31-249-8209
Ext
8209
Email
jminbae@gmail.com
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Min Bae, MD
Phone
82-31-249-8209
Email
jminbae@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30681166
Citation
Bae JM, Eun SH, Lee HN, Kim GM, Grimes PE, Lee JH. Comparison of 311-nm Titanium:Sapphire laser and 308-nm excimer laser treatment for vitiligo: A randomized controlled non-inferiority trial. Lasers Surg Med. 2019 Mar;51(3):239-244. doi: 10.1002/lsm.23048. Epub 2019 Jan 25.
Results Reference
derived

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

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