VitiligoPhase 4NCT01732965
NB-UVB and PUVA Vitiligo Study
A Phase 4 study testing Phototherapy and Phototherapy and Photochemotherapy in people with Vitiligo, run by Henry Ford Health System at 1 site in United States.
Trial summary
To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Phototherapy and Phototherapy and Photochemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to May 2014
- Phase
- Phase 4
- 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
- Vitiligo affecting more than 15% body surface area.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Open Parallel Right to Left Bilateral Study Comparing Narrowband Ultraviolet B Alone Versus Narrowband Ultraviolet B and Psoralen Plus Ultraviolet A for the Treatment of Vitiligo
To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.
- Conditions
- Vitiligo
- Being tested
- Phototherapy, Phototherapy and Photochemotherapy
- Keywords
- Vitiligo, Phototherapy, Photochemotherapy
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyOther
Phototherapy and PhotochemotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB phototherapy | Placebo comparator | NB-UVB alone Receives: Other: Phototherapy |
| phototherapy and photochemotherapy | Experimental | NB-UVB and PUVA Receives: Other: Phototherapy and Photochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the quantity of repigmentation
Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
Measured: 6 months
Secondary outcomes (1)
Determine the quality of repigmentation.
Determination of the color of repigmentation, pattern of repigmentation, and the cessation of spread of vitiligo after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
Measured: Study initiation, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionMay 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iltefat Hamzavi, Henry Ford Health System
- Investigators
- Iltefat Hamzavi, MD, Principal investigator, Henry Ford Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732965
- Sponsor's protocol ID
- HFHS Vitiligo Phototherapy
- Status last verified
- Feb 2017
- First submitted
- 13 Nov 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open Parallel Right to Left Bilateral Study Comparing Narrowband Ultraviolet B Alone Versus Narrowband Ultraviolet B and Psoralen Plus Ultraviolet A for the Treatment of Vitiligo
- ClinicalTrials.gov ID
- NCT01732965
- Acronym / sponsor ID
- HFHS Vitiligo Phototherapy
- Conditions
- Vitiligo
- Keywords
- Vitiligo, Phototherapy, Photochemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Nov 2012 (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.
To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB-UVB phototherapy | Placebo comparator | Other: PhototherapyNB-UVB alone |
| phototherapy and photochemotherapy | Experimental | Other: Phototherapy and PhotochemotherapyNB-UVB and PUVA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vitiligo affecting more than 15% body surface area.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Phototherapy | Other | NB-UVB phototherapy |
| Phototherapy and Photochemotherapy | Other | phototherapy and photochemotherapy |
Primary outcome
Determine the quantity of repigmentation
Time frame: 6 months
Determination the degree of repigmentation measured by the VASI score (Vitiligo area Scoring Index) after treating with the combination treatments (narrowband ultraviolet B and topical psoralen plus ultraviolet A) and compare it with narrowband ultraviolet B alone.
1 secondary outcome
Determine the quality of repigmentation.
Time frame: Study initiation, 3 months and 6 months.
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 23 Feb 2017.
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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.
Iltefat Hamzavi, MD principal investigator
Henry Ford Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phototherapy and Phototherapy and Photochemotherapy in people with Vitiligo, run by Henry Ford Health System 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 1 inclusion and 0 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 23 Feb 2017. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine the quantity of repigmentation (time frame: 6 months). 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 23 Feb 2017.