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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
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brief Description of Focus of Study Instead

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 23, 2018
Last Updated
February 5, 2020
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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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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