VitiligoPhase 2NCT01787708
Efficacy of Red Light in Vitiligo
A Phase 2 study testing Red light in people with Vitiligo, run by University of British Columbia at 1 site in Canada.
Trial summary
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Red light
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Dec 2015
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Localized or generalized vitiligo that involves a non mucosal or acral site.
- Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually
Who cannot join
- Patients who received treatment for vitiligo within the past 3 weeks.
- Patients known to have a photosensitivity disorder
- History of previous skin cancer.
- History of severe medical illness or immunosuppression.
- Pregnancy or breast-feeding.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Skin Care Center, Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E8
Harvey Lui, MD FRCPC, 16048754111, harvey.lui@ubc.ca
Harvey Lui, MD FRCPC
About this study
Official title: Efficacy of Red Light in Vitiligo: A Prospective, Single-Blind Randomized Controlled Trial
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.
Read the detailed description
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.
There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.
Study Objective To evaluate the potential for red light to induce repigmentation within vitiligo patches.
- Conditions
- Vitiligo
- Being tested
- Red light
- Keywords
- Vitiligo, red, laser, light
- Medical subject headings
- Vitiligo, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red lightProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Low intensity red laser | Active comparator | Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2).
Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. Receives: Procedure: Red light |
| High intensity red light | Active comparator | Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2).
Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. Receives: Procedure: Red light |
| No treatment1 (covered) | No intervention | Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. |
| No treatment2 (covered) | No intervention | Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the modified VASI score compared to baseline.
Measured: assessments at 2, 4, 6, 8 and 10 weeks during treatment then at 4, 8, and 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015 (estimated)
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 University of British ColumbiaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harvey Lui, MD, FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787708
- Sponsor's protocol ID
- H10-02235b
- Status last verified
- Jun 2015
- First submitted
- 4 Feb 2013
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Red Light in Vitiligo: A Prospective, Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01787708
- Acronym / sponsor ID
- H10-02235b
- Conditions
- Vitiligo
- Keywords
- Vitiligo, red, laser, light
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- 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 chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.
Detailed description
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.
There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo.
Study Objective To evaluate the potential for red light to induce repigmentation within vitiligo patches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low intensity red laser | Active comparator | Procedure: Red lightPatients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. |
| High intensity red light | Active comparator | Procedure: Red lightPatients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. |
| No treatment1 (covered) | No intervention | –Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. |
| No treatment2 (covered) | No intervention | –Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Localized or generalized vitiligo that involves a non mucosal or acral site.
- Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually
Key exclusion criteria (5 listed)
- Patients who received treatment for vitiligo within the past 3 weeks.
- Patients known to have a photosensitivity disorder
- History of previous skin cancer.
- History of severe medical illness or immunosuppression.
- Pregnancy or breast-feeding.
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 |
|---|---|---|
| Red light | Procedure or surgery | High intensity red light, Low intensity red laser |
Primary outcome
Change in the modified VASI score compared to baseline.
Time frame: assessments at 2, 4, 6, 8 and 10 weeks during treatment then at 4, 8, and 12 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
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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.
Harvey Lui, MD, FRCPC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Red light in people with Vitiligo, run by University of British Columbia at 1 site in Canada.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jul 2015. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harvey Lui, MD, FRCPC (16048754111, harvey.lui@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the modified VASI score compared to baseline. (time frame: assessments at 2, 4, 6, 8 and 10 weeks during treatment then at 4, 8, and 12 weeks post treatment). 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 2 Jul 2015.