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

NCT ID: NCT03384459

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-18

Study Completion Date

2019-05-18

Brief Summary

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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

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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.

Conditions

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Vitiligo Maintenance Therapy the 308-nm Excimer Laser Recurrence

Keywords

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vitiligo 308-nm excimer laser maintenance therapy recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

the 308-nm excimer laser

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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the 308-nm excimer laser

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Jung Min Bae

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Vincent's Hospital

Suwon, Gyonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung Min Bae, MD, PhD

Role: CONTACT

Phone: 82-31-249-7460

Email: [email protected]

Facility Contacts

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Jung Min Bae, MD, PhD

Role: primary

Other Identifiers

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VC17DEDI0186

Identifier Type: -

Identifier Source: org_study_id