VitiligoNCT03384459
Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo
A study testing the 308-nm excimer laser in people with Vitiligo and Maintenance Therapy, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Vitiligo, Maintenance Therapy, the 308-nm Excimer Laser
- What is being tested?
- the 308-nm excimer laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2017to 18 May 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age of 19 years or older
- Patients of generalized vitiligo with lesions on the trunk
- Patients who had treated with the 308-nm excimer laser previously and achieved more than 75% lesion improvement
- Patients who voluntarily agreed to participate in the study
Who cannot join
- Patients under the age of 19
- Patients with localized vitiligo and segmental vitiligo
- Patients who are in a state of physical or mental impairment to perform treatment or pregnant
- Patients with spreading of vitiligo lesions
- Patients who do not want to do thie study or who refuse to write a consent form
- Any other person deemed unsuitable for the examination at the discretion of the examiner
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
St. Vincent's Hospital
Suwon, Gyonggi-do, 16247
Jung Min Bae, MD, PhD, +82.31-249-7461, jminbae@gmail.com
About this study
Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy. The aim of this study was to evaluate the efficacy of 308-nm excimer laser therapy for the prevention of relapse in vitiligo.
Read the detailed description
For a total period of 12 months, perform the 308-nm excimer laser treatment once a month. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.
An independent evaluator will obtain the score of vitiligo area (Vitiligo Extent Score) from comparing clinical photographs of before registration and after the clinical trial, and judge whether vitiligo is recurred. This study is a randomized controlled trial, and the investigators plan to compare the recurrence rates of the experimental and control groups using the Chi-squared test.
- Conditions
- Vitiligo, Maintenance Therapy, the 308-nm Excimer Laser, Recurrence
- Being tested
- the 308-nm excimer laser
- Keywords
- vitiligo, 308-nm excimer laser, maintenance therapy, recurrence
- Medical subject headings
- Vitiligo, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the 308-nm excimer laserDevice
For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | For a total period of 12 months, perform the 308-nm excimer laser treatment once a month.
At this time, the dose of the 308-nm excimer laser is based on the 50% of the maximum dose that the patient received for the treatment.
Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.
If recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence. Receives: Device: the 308-nm excimer laser |
| Control group | No intervention | Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months. If recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of vitiligo
Clinical photographs taken before and 12 months after the completion of the study. The photographs will be used to measure the area of vitiligo lesion, and the investigators will compare the area score and judge whether or not there is a recurrence.
Measured: Change from Baseline area score at 12 months
Secondary outcomes (1)
The assessment of patient satisfaction
The assessment of patient satisfaction using five-point Likert scale (Scale 1: strongly not-satisfied, Scale 2: Not-satisfied, Scale 3: Neither satisfied nor not-satisfied, Scale 4: Satisfied, Scale 5: Strongly satisfied)
Measured: at Baseline and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start18 Nov 2017
- Primary completion18 Nov 2018 (estimated)
- Study completion18 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 100 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
- NCT03384459
- Sponsor's protocol ID
- VC17DEDI0186
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT03384459
- Acronym / sponsor ID
- VC17DEDI0186
- Conditions
- Vitiligo, Maintenance Therapy, the 308-nm Excimer Laser, Recurrence
- Keywords
- vitiligo, 308-nm excimer laser, maintenance therapy, recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 18 Nov 2018 (estimated)
- Study completion
- 18 May 2019 (estimated)
- First posted
- 27 Dec 2017 (actual)
- 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.
Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy. The aim of this study was to evaluate the efficacy of 308-nm excimer laser therapy for the prevention of relapse in vitiligo.
Detailed description
For a total period of 12 months, perform the 308-nm excimer laser treatment once a month. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.
An independent evaluator will obtain the score of vitiligo area (Vitiligo Extent Score) from comparing clinical photographs of before registration and after the clinical trial, and judge whether vitiligo is recurred. This study is a randomized controlled trial, and the investigators plan to compare the recurrence rates of the experimental and control groups using the Chi-squared test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: the 308-nm excimer laserFor a total period of 12 months, perform the 308-nm excimer laser treatment once a month. At this time, the dose of the 308-nm excimer laser is based on the 50% of the maximum dose that the patient received for the treatment. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months. If recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence. |
| Control group | No intervention | –Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months. If recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with age of 19 years or older
- Patients of generalized vitiligo with lesions on the trunk
- Patients who had treated with the 308-nm excimer laser previously and achieved more than 75% lesion improvement
- Patients who voluntarily agreed to participate in the study
Key exclusion criteria (6 listed)
- Patients under the age of 19
- Patients with localized vitiligo and segmental vitiligo
- Patients who are in a state of physical or mental impairment to perform treatment or pregnant
- Patients with spreading of vitiligo lesions
- Patients who do not want to do thie study or who refuse to write a consent form
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 |
|---|---|---|
| the 308-nm excimer laserFor a total period of 12 months, the 308-nm excimer laser therapy is performed once a month. | Device | Experimental group |
Primary outcome
Recurrence of vitiligo
Time frame: Change from Baseline area score at 12 months
Clinical photographs taken before and 12 months after the completion of the study. The photographs will be used to measure the area of vitiligo lesion, and the investigators will compare the area score and judge whether or not there is a recurrence.
1 secondary outcome
The assessment of patient satisfaction
Time frame: at Baseline and at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: No
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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 the 308-nm excimer laser in people with Vitiligo and Maintenance Therapy, 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 4 inclusion and 6 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 27 Dec 2017. 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 (82-31-249-7460, jminbae@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of vitiligo (time frame: Change from Baseline area score at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2017.