Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2018
CompletedJanuary 19, 2018
January 1, 2018
1.5 years
October 3, 2016
January 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The adverse effects of both two laser treatments
At 4 weeks, 8 weeks, and 12 weeks
Study Arms (2)
The 311-nm Ti:Sapphire laser treatment group
EXPERIMENTALAll lesions were treated twice weekly for a total of 12-week period.
The 308-nm excimer laser treatment group
ACTIVE COMPARATORAll lesions were treated twice weekly for a total of 12-week period.
Interventions
Pallas, LaserOptek, South Korea
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247, South Korea
Related Publications (1)
Bae JM, Eun SH, Lee HN, Kim GM, Grimes PE, Lee JH. Comparison of 311-nm Titanium:Sapphire laser and 308-nm excimer laser treatment for vitiligo: A randomized controlled non-inferiority trial. Lasers Surg Med. 2019 Mar;51(3):239-244. doi: 10.1002/lsm.23048. Epub 2019 Jan 25.
PMID: 30681166DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 6, 2016
Study Start
August 1, 2016
Primary Completion
January 30, 2018
Study Completion
August 30, 2018
Last Updated
January 19, 2018
Record last verified: 2018-01