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

March 4, 2019 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators initiate this open, randomized, left-right comparative study to evaluate the efficacy of pulsed ultrasound in the treatment of vitiligo on the face or trunk. Face is included in this study because vitiliginous lesions on the face has a better treatment response and causes more psychological distress on the patients than vitiligo affecting other body areas. Thirty adult subjects with vitiligo affecting the face or trunk symmetrically will be recruited. After randomization, subjects will be administrated their ulrasound treatment twice a week for 24 weeks. Their original topical treatment and/or phototherapy will be continued. During follow-up visits, digital photographs will be taken for evaluating the extent of residual depigmentation. In vivo harmonic microscopy and three skin biopsy specimens will be performed at the indicated time points on the depigmented, repigmented areas and surrounding normal skin.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 20-75 years old
  2. With skin type Ⅲ or Ⅳ
  3. With Vitiligo
  4. Can read the informed consent form
  5. Can continue the original treatments

Exclusion Criteria:

  1. With segmental vitiligo.
  2. Have joined other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitiligo
30 Patients with Vitiligo
Device: HGM
To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 participants with Vitiligo as assessed by Harmonic Generation Microscopy.
Time Frame: 1-2 hours per case
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yi-Hua Liao, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

October 23, 2014

Study Completion (Actual)

December 9, 2015

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (Actual)

March 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201403043DINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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