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The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718962
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

Tracking Information
First Submitted Date  ICMJE October 23, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date January 2, 2020
Actual Study Start Date  ICMJE October 30, 2018
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
repigmentation [ Time Frame: 12weeks ]
repigmentation amount
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03718962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
Official Title  ICMJE The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brief Description of Focus of Study Instead
Intervention  ICMJE
  • Device: Surrounding needling+ phototherapy
    Surrounding needling+ phototherapy
    Other Name: phototherapy
  • Device: phototherapy
    phototherapy
Study Arms  ICMJE
  • Active Comparator: needling
    Intervention: Device: Surrounding needling+ phototherapy
  • Placebo Comparator: phototherapy
    Intervention: Device: phototherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Actual Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Clinical diagnosis of Vitiligo

Exclusion Criteria:

  • pregnancy
  • immune disorder
  • infection
  • other dermatosis in treating areas
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gong Yau Chu, MD 886 987057172 aguest122@hotmail.com.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03718962
Other Study ID Numbers  ICMJE 20180205R
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shin Kong Wu Ho-Su Memorial Hospital
Study Sponsor  ICMJE Shin Kong Wu Ho-Su Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shin Kong Wu Ho-Su Memorial Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP