Maintenance Therapy, Recurrence, the 308-nm Excimer Laser, Vitiligo
Conditions
Keywords
vitiligo, 308-nm excimer laser, maintenance therapy, recurrence
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.
Interventions
DEVICEthe 308-nm excimer laser
For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with age of 19 years or older 2. Patients of generalized vitiligo with lesions on the trunk 3. Patients who had treated with the 308-nm excimer laser previously and achieved more than 75% lesion improvement 4. Patients who voluntarily agreed to participate in the study
Exclusion criteria
1. Patients under the age of 19 2. Patients with localized vitiligo and segmental vitiligo 3. Patients who are in a state of physical or mental impairment to perform treatment or pregnant 4. Patients with spreading of vitiligo lesions 5. Patients who do not want to do thie study or who refuse to write a consent form 6. Any other person deemed unsuitable for the examination at the discretion of the examiner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of vitiligo | 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
| Measure | Time frame | Description |
|---|---|---|
| The assessment of patient satisfaction | at Baseline and at 12 months | 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) |
Countries
South Korea
Contacts
Primary ContactJung Min Bae, MD, PhD
Outcome results
None listed