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

Not Applicable

• Conditions: Maintenance Therapy; Vitiligo; the 308-nm Excimer Laser; Recurrence
• Interventions: Device: the 308-nm excimer laser

• Registration Number: NCT03384459
• Lead Sponsor: The Catholic University of Korea

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 Timeline

• Study Start: 2017-11-18
• Status Verified: 2017-12
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-25
• Last Update Submitted: 2017-12-25
• Study First Posted: 2017-12-27
• Last Update Posted: 2017-12-27
• Primary Completion: 2018-11-18
• Study Completion: 2019-05-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	the 308-nm excimer laser	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Gyonggi-do, Korea, Republic of