- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03384342
Maintenance Therapy of Narrow-band UV-B 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 Narrow-band UV-B therapy for the prevention of relapse in vitiligo.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For a total period of 12 months, perform Narrow-band UV-B 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyonggi-do
-
Suwon, Gyonggi-do, Korea, Republic of, 16247
- Recruiting
- St. Vincent's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with age of 19 years or older
- Patients of generalized vitiligo with lesions on the trunk
- Patients who had treated with Narrow-band UV-B therapy 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental group
|
|
NO_INTERVENTION: Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of vitiligo
Time Frame: 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.
|
change from baseline area score at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The assessment of patient satisfaction
Time Frame: 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)
|
at baseline and at 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VC17DEDI0185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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