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

The Catholic University of Korea

Status: Unknown

Conditions: Vitiligo

Treatments: Device: 311-nm Ti:Sapphire laser; Device: 308-nm excimer laser

Study type: Interventional

Funder types: Other

Identifiers

NCT02925767

VC16DISI0088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

The 311-nm Ti:Sapphire laser treatment group

Experimental group

Description:

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

Treatment:

Device: 311-nm Ti:Sapphire laser

The 308-nm excimer laser treatment group

Active Comparator group

Description:

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

Treatment:

Device: 308-nm excimer laser