VitiligoNCT00398723
Narrowband UVB Treatment in Patients With Vitiligo
A study testing Narrowband UVB in people with Vitiligo, run by Mary Sullivan-Whalen at 1 site in United States.
Trial summary
The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo. The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Narrowband UVB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Nov 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age or greater
- Vitiligo with extensive skin involvement (>5% body surface affected).
Who cannot join
- No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study.
- No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockefeller University Hospital
New York, New York, 10021
About this study
Official title: Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo
The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo.
The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.
Read the detailed description
All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.
- Conditions
- Vitiligo
- Being tested
- Narrowband UVB
- Keywords
- Narrowband UBV Phototherapy, Skin biopsies
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrowband UVBDevice
Treatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo | Experimental | adult patients (age 18 or greater) with extensive vitiligo warranting treatment with whole body NB-UVB Receives: Device: Narrowband UVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of melanocytes per unit length of skin surface
Measured: pre-treatment, early repigmentation, 75% repigmentation of total body
Secondary outcomes (1)
Clinical improvement
Measured: first visit and last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2007
- Study completionNov 2007
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Sullivan-Whalen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Sullivan-Whalen, Rockefeller University
- Investigators
- James Krueger, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398723
- Sponsor's protocol ID
- RUH IRB # JCO 0590
- Status last verified
- Oct 2011
- First submitted
- 10 Nov 2006
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Narrowband UVB Phototherapy on Melanocyte Proliferation in Patients With Vitiligo
- ClinicalTrials.gov ID
- NCT00398723
- Acronym / sponsor ID
- RUH IRB # JCO 0590
- Conditions
- Vitiligo
- Keywords
- Narrowband UBV Phototherapy, Skin biopsies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mary Sullivan-WhalenUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 14 Nov 2006 (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.
The study offers narrowband UVB light therapy to patients who have 5% of their body involved with vitiligo.
The hypothesis is that Narrowband UVB promotes melanocyte proliferation in vitiligo lesions.
Detailed description
All patients will receive phototherapy, with narrowband UVB, three times a week for six months, or a total of 78 treatments. 6mm punch skin biopsies (2) will be done prior to starting therapy, once during treatment (2) and at the completion of the study (2). Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitiligo | Experimental | Device: Narrowband UVBadult patients (age 18 or greater) with extensive vitiligo warranting treatment with whole body NB-UVB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years of age or greater
- Vitiligo with extensive skin involvement (>5% body surface affected).
Key exclusion criteria (2 listed)
- No treatment with topical steroids, calcineurin inhibitors or vitamin D analogs for at least 4 weeks prior to entering the study.
- No treatment with systemic therapies, including methotrexate, etretinate, PUVA, or cyclosporine 4 weeks prior to entering the study.
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 |
|---|---|---|
| Narrowband UVBTreatment three to seven times weekly for a total of 12 to 26 weeks (36 to 168 treatments). Dosing of NB-UVB will begin at 100-280 mJ/cm2, depending on tolerance and skin type, and will be titrated 10-20% per session until clinical efficacy or symptomatic erythema | Device | Vitiligo |
Primary outcome
Number of melanocytes per unit length of skin surface
Time frame: pre-treatment, early repigmentation, 75% repigmentation of total body
1 secondary outcome
Clinical improvement
Time frame: first visit and last visit
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 13 Oct 2011.
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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.
James Krueger, MD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrowband UVB in people with Vitiligo, run by Mary Sullivan-Whalen at 1 site in United States.
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 2 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 13 Oct 2011. 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 United States. 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?
Number of melanocytes per unit length of skin surface (time frame: pre-treatment, early repigmentation, 75% repigmentation of total body). 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 13 Oct 2011.