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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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The 311-nm Ti:Sapphire laser treatment group

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

Group Type EXPERIMENTAL

311-nm Ti:Sapphire laser

Intervention Type DEVICE

Pallas, LaserOptek, South Korea

The 308-nm excimer laser treatment group

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

Group Type ACTIVE_COMPARATOR

308-nm excimer laser

Intervention Type DEVICE

XTRAC, PhotoMedex, US

Interventions

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311-nm Ti:Sapphire laser

Pallas, LaserOptek, South Korea

Intervention Type DEVICE

308-nm excimer laser

XTRAC, PhotoMedex, US

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes