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

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03864315
• Other study ID #: 201403043DINC
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: December 9, 2015

Study information

• Verified date: February 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 9, 2015
• Est. primary completion date: October 23, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 20-75 years old

2. With skin type ? or ?

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

Related Conditions & MeSH terms

• Vitiligo

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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