Brief Description of Focus of Study InsteadNCT03718962
The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
A study testing Surrounding needling+ phototherapy and phototherapy in people with Brief Description of Focus of Study Instead, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Brief Description of Focus of Study Instead
- What is being tested?
- Surrounding needling+ phototherapy and phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Oct 2018to 30 Jan 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Vitiligo
Who cannot join
- pregnancy
- immune disorder
- infection
- other dermatosis in treating areas
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Surrounding needling+ phototherapy, phototherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surrounding needling+ phototherapyDevice
Also called phototherapy
Surrounding needling+ phototherapy
phototherapyDevice
phototherapy
| Study group | Role | What they receive |
|---|---|---|
| needling | Active comparator | needling + phototherapy Receives: Device: Surrounding needling+ phototherapy |
| phototherapy | Placebo comparator | phototherapy Receives: Device: phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
repigmentation
repigmentation amount
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start30 Oct 2018
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brief Description of Focus of Study InsteadStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718962
- Sponsor's protocol ID
- 20180205R
- Status last verified
- Dec 2019
- First submitted
- 23 Oct 2018
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of UVB Phototherapy With Microneedling and Circled Needing in Vitiligo Patients
- ClinicalTrials.gov ID
- NCT03718962
- Acronym / sponsor ID
- 20180205R
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 25 Oct 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| needling | Active comparator | Device: Surrounding needling+ phototherapyneedling + phototherapy |
| phototherapy | Placebo comparator | Device: phototherapyphototherapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Vitiligo
Key exclusion criteria (4 listed)
- pregnancy
- immune disorder
- infection
- other dermatosis in treating areas
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 |
|---|---|---|
| Surrounding needling+ phototherapyAlso: phototherapySurrounding needling+ phototherapy | Device | needling |
| phototherapyphototherapy | Device | phototherapy |
Primary outcome
repigmentation
Time frame: 12weeks
repigmentation amount
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 7 Feb 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surrounding needling+ phototherapy and phototherapy in people with Brief Description of Focus of Study Instead, run by Shin Kong Wu Ho-Su Memorial 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 1 inclusion and 4 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 7 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
repigmentation (time frame: 12weeks). 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 7 Feb 2020.