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Status unknownNCT02925767Updated Jan 19, 2018

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

An interventional study of 311-nm Ti:Sapphire laser and 308-nm excimer laser in Vitiligo, sponsored by The Catholic University of Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

  • Vitiligo

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In context

Vitiligo

298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.

This study's planned enrollment of 16 is below the median of 30 across 227 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

The Catholic University of Korea is the lead sponsor of 150 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    The 311-nm Ti:Sapphire laser treatment group

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

    Device: 311-nm Ti:Sapphire laser

  • Active comparator
    The 308-nm excimer laser treatment group

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

    Device: 308-nm excimer laser

Interventions

  • Device311-nm Ti:Sapphire laser

    Pallas, LaserOptek, South Korea

  • Device308-nm excimer laser

    XTRAC, PhotoMedex, US

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What researchers measure

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.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. The adverse effects of both two laser treatments

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

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Study locations

1 of 1 sites recruiting
  • St. Vincent's Hospital
    Suwon, Gyeonggi-do 16247, Korea, Republic of
    Recruiting
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References and documents

Publications

  • 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. PubMed 30681166 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02925767
Lead sponsor
The Catholic University of Korea
Responsible party
Jung Min Bae (Clinical Assistant Professor, The Catholic University of Korea) — Principal investigator
First posted
Oct 6, 2016
Start date
Aug 2016
Primary completion
Jan 30, 2018 (estimated)
Completion
Aug 30, 2018 (estimated)
Last update
Jan 19, 2018

Study contacts

Jung Min Bae, MD, PhD
Contact
jminbae@gmail.com
82-31-249-8209 ext. 8209

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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