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

Study Overview
=================
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.

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

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Device: 311-nm Ti:Sapphire laser
* Device: 308-nm excimer laser


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The 311-nm Ti:Sapphire laser treatment group<br>All lesions were treated twice weekly for a total of 12-week period. | Device: 311-nm Ti:Sapphire laser<br>* Pallas, LaserOptek, South Korea<br>|
| Active Comparator: The 308-nm excimer laser treatment group<br>All lesions were treated twice weekly for a total of 12-week period. | Device: 308-nm excimer laser<br>* XTRAC, PhotoMedex, US<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 12 weeks | 

Secondary Outcome Measures

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