VitiligoNCT03864315
To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
A study testing HGM in people with Vitiligo, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- HGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2014to 9 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-75 years old
- With skin type Ⅲ or Ⅳ
- With Vitiligo
- Can read the informed consent form
- Can continue the original treatments
Who cannot join
- With segmental vitiligo.
- Have joined other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Vitiligo
- Being tested
- HGM
- Keywords
- Vitiligo, Harmonic Generation Microscopy, In Vivo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGMDevice
To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo | Experimental | 30 Patients with Vitiligo Receives: Device: HGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 hours per case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Jul 2014
- Primary completion23 Oct 2014
- Study completion9 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hua Liao, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864315
- Sponsor's protocol ID
- 201403043DINC
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
- ClinicalTrials.gov ID
- NCT03864315
- Acronym / sponsor ID
- 201403043DINC
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Harmonic Generation Microscopy, In Vivo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 23 Oct 2014 (actual)
- Study completion
- 9 Dec 2015 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitiligo | Experimental | Device: HGM30 Patients with Vitiligo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20-75 years old
- With skin type Ⅲ or Ⅳ
- With Vitiligo
- Can read the informed consent form
- Can continue the original treatments
Key exclusion criteria (2 listed)
- With segmental vitiligo.
- Have joined other clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGMTo Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study | Device | Vitiligo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Hua Liao principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HGM in people with Vitiligo, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 participants with Vitiligo as assessed by Harmonic Generation Microscopy. (time frame: 1-2 hours per case). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.