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

The Catholic University of Korea16 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vitiligo

Interventions

311-nm Ti:Sapphire laserDEVICE

Pallas, LaserOptek, South Korea

308-nm excimer laserDEVICE

XTRAC, PhotoMedex, US

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 weeks

Secondary Outcomes

The adverse effects of both two laser treatments

Time frame: At 4 weeks, 8 weeks, and 12 weeks

Central Contacts

Jung Min Bae, MD, PhD

CONTACT

82-31-249-8209 jminbae@gmail.com

Data from ClinicalTrials.gov

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