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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03384459
• Other study ID #: VC17DEDI0186
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2017
• Last updated: December 25, 2017
• Start date: November 18, 2017
• Est. completion date: May 18, 2019

Study information

• Verified date: December 2017
• Source: The Catholic University of Korea
• Contact: Jung Min Bae, MD, PhD
• Phone: 82-31-249-7460
• Email: jminbae[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 18, 2019
• Est. primary completion date: November 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Maintenance Therapy
• Recurrence
• the 308-nm Excimer Laser
• Vitiligo

Intervention

Device:
• the 308-nm excimer laser
For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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