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

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ClinicalTrials.gov Identifier: NCT02925767
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jung Min Bae, The Catholic University of Korea

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.

Condition or disease Intervention/treatment Phase
Vitiligo Device: 311-nm Ti:Sapphire laser Device: 308-nm excimer laser Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
Study Start Date : August 2016
Estimated Primary Completion Date : January 30, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
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
Pallas, LaserOptek, South Korea

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
XTRAC, PhotoMedex, US




Primary Outcome Measures :
  1. The repigmentation rate (change from baseline) of the vitiliginous patch [ Time Frame: Baseline and 12 weeks ]
    The degree of repigmentation will be assessed as % from baseline by using a computer program.


Secondary Outcome Measures :
  1. The adverse effects of both two laser treatments [ Time Frame: At 4 weeks, 8 weeks, and 12 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925767


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

Locations
Korea, Republic of
St. Vincent's Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Contact: Jung Min Bae, MD    82-31-249-8209    jminbae@gmail.com   
Sponsors and Collaborators
The Catholic University of Korea

Responsible Party: Jung Min Bae, Clinical Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02925767     History of Changes
Other Study ID Numbers: VC16DISI0088
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases