An interventional study of the 308-nm excimer laser in Vitiligo, Maintenance Therapy and the 308-nm Excimer Laser, sponsored by The Catholic University of Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-12-27.
Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Treatment
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.
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 100 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →The Catholic University of Korea is the lead sponsor of 155 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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.
Device: the 308-nm excimer laser
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.
For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.
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.
Time frame: Change from Baseline area score at 12 months
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)
Time frame: at Baseline and at 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Nov 2018, 12 months after the start.
Of 63 non-industry interventional studies with no phase under Vitiligo, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 12 months is below that.
Counting every sponsor, half of 67 studies reached it within 17 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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