NCT03864315

Brief Summary

In this study, the investigators demonstrated that in vivo THG microscopy can differentiate vitiligo lesions and normal skin based the optical nature of melanin. This THG-based procedure provides a valuable tool for noninvasive determination of third-order nonlinear susceptibility of melanin within the skin. It can also provide real-time histopathology information for treatment follow-up, without performing invasive skin biopsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 25, 2019

Last Update Submit

March 4, 2019

Conditions

Vitiligo

Keywords

VitiligoHarmonic Generation MicroscopyIn Vivo

Outcome Measures

Primary Outcomes (1)

  • 30 participants with Vitiligo as assessed by Harmonic Generation Microscopy.

    The HGM system will be combined to provide the noninvasive microscopic images in Vitiligo sites during each follow-up for pathological diagnosis.

    1-2 hours per case

Study Arms (1)

Vitiligo

EXPERIMENTAL

30 Patients with Vitiligo

Device: HGM

Interventions

HGMDEVICE

To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study

Vitiligo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • With skin type Ⅲ or Ⅳ
  • With Vitiligo
  • Can read the informed consent form
  • Can continue the original treatments

You may not qualify if:

  • With segmental vitiligo.
  • Have joined other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yi-Hua Liao

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 6, 2019

Study Start

July 1, 2014

Primary Completion

October 23, 2014

Study Completion

December 9, 2015

Last Updated

March 6, 2019

Record last verified: 2019-02

Locations

TW(1)