VitiligoNCT02925767
Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
A study testing 311-nm Ti:Sapphire laser and 308-nm excimer laser in people with Vitiligo, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- 311-nm Ti:Sapphire laser and 308-nm excimer laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Jung Min Bae, MD, 82-31-249-8209, jminbae@gmail.com
About this study
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.
- Conditions
- Vitiligo
- Being tested
- 311-nm Ti:Sapphire laser, 308-nm excimer laser
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
311-nm Ti:Sapphire laserDevice
Pallas, LaserOptek, South Korea
308-nm excimer laserDevice
XTRAC, PhotoMedex, US
| Study group | Role | What they receive |
|---|---|---|
| The 311-nm Ti:Sapphire laser treatment group | Experimental | All lesions were treated twice weekly for a total of 12-week period. Receives: Device: 311-nm Ti:Sapphire laser |
| The 308-nm excimer laser treatment group | Active comparator | All lesions were treated twice weekly for a total of 12-week period. Receives: Device: 308-nm excimer laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
The adverse effects of both two laser treatments
Measured: At 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startAug 2016
- Primary completion30 Jan 2018 (estimated)
- Study completion30 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Min Bae, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925767
- Sponsor's protocol ID
- VC16DISI0088
- Status last verified
- Jan 2018
- First submitted
- 3 Oct 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
- ClinicalTrials.gov ID
- NCT02925767
- Acronym / sponsor ID
- VC16DISI0088
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 30 Jan 2018 (estimated)
- Study completion
- 30 Aug 2018 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The 311-nm Ti:Sapphire laser treatment group | Experimental | Device: 311-nm Ti:Sapphire laserAll lesions were treated twice weekly for a total of 12-week period. |
| The 308-nm excimer laser treatment group | Active comparator | Device: 308-nm excimer laserAll lesions were treated twice weekly for a total of 12-week period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 311-nm Ti:Sapphire laserPallas, LaserOptek, South Korea | Device | The 311-nm Ti:Sapphire laser treatment group |
| 308-nm excimer laserXTRAC, PhotoMedex, US | Device | The 308-nm excimer laser treatment group |
Primary outcome
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.
1 secondary outcome
The adverse effects of both two laser treatments
Time frame: At 4 weeks, 8 weeks, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Derived from this study: PubMed 30681166Bae 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 311-nm Ti:Sapphire laser and 308-nm excimer laser in people with Vitiligo, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Min Bae, MD, PhD (82-31-249-8209 ext. 8209, jminbae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The repigmentation rate (change from baseline) of the vitiliginous patch (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02925767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.