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

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.

Study Overview

• Status: Unknown
• Conditions: Recurrence; Vitiligo; Maintenance Therapy; the 308-nm Excimer Laser
• Intervention / Treatment: Device: the 308-nm excimer laser

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyonggi-do
    • Suwon, Gyonggi-do, Korea, Republic of, 16247
      • Recruiting
      • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: the 308-nm excimer laser; For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from Baseline area score at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	at Baseline and at 12 months

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2017
• Primary Completion (Anticipated): November 18, 2018
• Study Completion (Anticipated): May 18, 2019

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 25, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 25, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: recurrence; vitiligo; maintenance therapy; 308-nm excimer laser
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Pigmentation Disorders; Hypopigmentation; Recurrence; Vitiligo
• Other Study ID Numbers: VC17DEDI0186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No