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

Not Applicable

• Conditions: Vitiligo
• Interventions: Device: 308-nm excimer laser

• Registration Number: NCT02925767
• Lead Sponsor: The Catholic University of Korea

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-19
• Primary Completion: 2018-01-30
• Study Completion: 2018-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The 308-nm excimer laser treatment group	308-nm excimer laser	All lesions were treated twice weekly for a total of 12-week period.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The adverse effects of both two laser treatments	At 4 weeks, 8 weeks, and 12 weeks

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of