Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Recurrence of vitiligo
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Experimental group
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.
Intervention: the 308-nm excimer laser (Device)
Control group
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The assessment of patient satisfaction(at Baseline and at 12 months)
Investigators
Jung Min Bae
Assistant Professor
The Catholic University of Korea