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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02925767
• Other study ID #: VC16DISI0088
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2016
• Last updated: January 18, 2018
• Start date: August 2016
• Est. completion date: August 30, 2018

Study information

• Verified date: January 2018
• Source: The Catholic University of Korea
• Contact: Jung Min Bae, MD, PhD
• Phone: 82-31-249-8209
• Email: jminbae[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: August 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

Device:
• 311-nm Ti:Sapphire laser
Pallas, LaserOptek, South Korea
• 308-nm excimer laser
XTRAC, PhotoMedex, US

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The adverse effects of both two laser treatments		At 4 weeks, 8 weeks, and 12 weeks