The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
Primary Purpose
Brief Description of Focus of Study Instead
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Surrounding needling+ phototherapy
phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Brief Description of Focus of Study Instead
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Vitiligo
Exclusion Criteria:
- pregnancy
- immune disorder
- infection
- other dermatosis in treating areas
Sites / Locations
- ShinKongHospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
needling
phototherapy
Arm Description
needling + phototherapy
phototherapy
Outcomes
Primary Outcome Measures
repigmentation
repigmentation amount
Secondary Outcome Measures
Full Information
NCT ID
NCT03718962
First Posted
October 23, 2018
Last Updated
February 5, 2020
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03718962
Brief Title
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
Official Title
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Vitiligo is a relatively common acquired disorder of pigmentation characterized by the development of well-defined white macules on the skin. Biopsies of lesional skin reveal a loss of epidermal melanocytes. Lesions may occur in a localized or generalized distribution and may coalesce into large, depigmented areas. Given the contrast between the white areas and normal skin, the disease is most disfiguring in darker skin types and has a profound impact on the quality of life of both children and adults . Patients with vitiligo often experience stigmatization, social isolation, and low self-esteem. The therapys include topical steroids, topical immunosuppresant, systemic steroids, phototherapy, and surgery.
The aim of this study is to investigate the effect of phototherpy and accupuncture combined therapy for vitiligo patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brief Description of Focus of Study Instead
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
needling
Arm Type
Active Comparator
Arm Description
needling + phototherapy
Arm Title
phototherapy
Arm Type
Placebo Comparator
Arm Description
phototherapy
Intervention Type
Device
Intervention Name(s)
Surrounding needling+ phototherapy
Other Intervention Name(s)
phototherapy
Intervention Description
Surrounding needling+ phototherapy
Intervention Type
Device
Intervention Name(s)
phototherapy
Intervention Description
phototherapy
Primary Outcome Measure Information:
Title
repigmentation
Description
repigmentation amount
Time Frame
12weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Vitiligo
Exclusion Criteria:
pregnancy
immune disorder
infection
other dermatosis in treating areas
Facility Information:
Facility Name
ShinKongHospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
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