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

Primary Purpose

Vitiligo, Maintenance Therapy, the 308-nm Excimer Laser

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
the 308-nm excimer laser
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, 308-nm excimer laser, maintenance therapy, recurrence

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Vincent's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm 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.

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 Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
December 5, 2017
Last Updated
December 25, 2017
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03384459
Brief Title
Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo
Official Title
Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2017 (Actual)
Primary Completion Date
November 18, 2018 (Anticipated)
Study Completion Date
May 18, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Maintenance Therapy, the 308-nm Excimer Laser, Recurrence
Keywords
vitiligo, 308-nm excimer laser, maintenance therapy, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
the 308-nm excimer laser
Intervention Description
For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.
Primary Outcome Measure Information:
Title
Recurrence of vitiligo
Description
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.
Time Frame
Change from Baseline area score at 12 months
Secondary Outcome Measure Information:
Title
The assessment of patient satisfaction
Description
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)
Time Frame
at Baseline and at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Min Bae, MD, PhD
Phone
82-31-249-7460
Email
jminbae@gmail.com
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
State/Province
Gyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Min Bae, MD, PhD
Phone
+82.31-249-7461
Email
jminbae@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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