NCT03718962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 7, 2020

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

October 23, 2018

Last Update Submit

February 5, 2020

Conditions

Brief Description of Focus of Study Instead

Outcome Measures

Primary Outcomes (1)

  • repigmentation

    repigmentation amount

    12weeks

Study Arms (2)

needling

ACTIVE COMPARATOR

needling + phototherapy

Device: Surrounding needling+ phototherapy

phototherapy

PLACEBO COMPARATOR

phototherapy

Device: phototherapy

Interventions

Surrounding needling+ phototherapyDEVICE

Surrounding needling+ phototherapy

Also known as: phototherapy
needling
phototherapyDEVICE

phototherapy

phototherapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Vitiligo

You may not qualify if:

  • pregnancy
  • immune disorder
  • infection
  • other dermatosis in treating areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ShinKongHospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Phototherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

October 30, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

February 7, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)