Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo

The Catholic University of Korea

Status: Unknown

Conditions: Maintenance Therapy; Vitiligo; the 308-nm Excimer Laser; Recurrence

Treatments: Device: the 308-nm excimer laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03384459

VC17DEDI0186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Device: the 308-nm excimer laser

Control group

No Intervention group

Description:

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.