VitiligoPhase 3VETFNCT00525395
Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol
A Phase 3 study testing Sequential phototherapy and Continuous phototherapy in people with Vitiligo, run by Istituti Fisioterapici Ospitalieri at 1 site in Italy.
Trial summary
Background Phototherapy UVB TL01 currently represents the first choice in treatment to induce the repigmentation of vitiligo spots. The problem though is that there are no systems or scales which enable an objective evaluation of the therapy, commonly known as percentage of repigmentation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Sequential phototherapy and Continuous phototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2007to Jun 2011
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 60 years old
Who cannot join
- Phototype I
- Previous treatment with any kind of phototherapy in the last 6 months.
- Patients with counter indications for PUVA or phototherapy (history of skin cancer, pregnancy, etc.).
- Acral vitiligo (only hands and feet are affected).
Trial locations and contacts
1 site in 1 country.
Mauro Picardo, MD contact
Italy1 site, 1 recruiting
- Recruiting
Istituto San Gallicano -
Rome, Rome, 00100
Mauro Picardo, MD, picardo@ifo.it
About this study
Official title: Continuative vs Sequential Phototherapy in Non-segmental Vitiligo Patients
Background
Phototherapy UVB TL01 currently represents the first choice in treatment to induce the repigmentation of vitiligo spots. The problem though is that there are no systems or scales which enable an objective evaluation of the therapy, commonly known as percentage of repigmentation.
Read more
Recently, a European Task Force (VETF, Vitiligo European Task Force) of experts on vitiligo, within the European Society of Pigmentation, has proposed a gravity classification on the basis of three parameters/standards - extension, progression and the level of depigmentation - and used to classify patients in ten European centres. The aim of the trial is to validate the VETF scoring system set up in relation with the therapeutic answer to the standard treatment for vitiligo and phototherapy.
Leaving aside short term side effects, such as sunrush/erythema and sunburn, which are reversible and infrequent, the main problem with phototherapy is represented by the cumulative long term effects of ultraviolet rays. These can cause premature ageing of the skin (photoaging) and the appearance of skin cancer/neoplasia. Therefore the aim is to get the best results from phototherapy whilst limiting its length.
Aims of the trial:
- To validate the VETF scoring system. As phototherapy is currently the only universally accepted treatment for vitiligo, it seems logical to test the VETF scoring system first to evaluate the effectiveness of phototherapy.
- Secondly, the target of this multicentric trial is to compare the effectiveness of two different phototherapy protocols; a first protocol foresees non-stop treatment for 6 months; a second protocol foresees periods of interruption during the treatment. This will help to verify whether interrupting a cycle of phototherapy is useful or not.
This interruption might make the ultraviolet rays more effective 'stimulus on the melanocytes', and may also reduce long term damage caused by phototherapy.
- Conditions
- Vitiligo
- Being tested
- Sequential phototherapy, Continuous phototherapy
- Keywords
- Phototherapy, Vitiligo scoring system
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential phototherapyGenetic
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
Continuous phototherapyProcedure or surgery
Group B: 6 months non-stop treatment.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment Receives: Genetic: Sequential phototherapy |
| B | Active comparator | Group B: 6 months non-stop treatment. Receives: Procedure: Continuous phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Fisioterapici Ospitalieri
- Sponsor type
- University, hospital or other
- Investigators
- Mauro Picardo, MD, Study chair, Istituto San Gallicano - Rome - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525395
- Sponsor's protocol ID
- VETF01
- Acronym
- VETF
- Status last verified
- Jun 2010
- First submitted
- 4 Sep 2007
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuative vs Sequential Phototherapy in Non-segmental Vitiligo Patients
- ClinicalTrials.gov ID
- NCT00525395
- Acronym / sponsor ID
- VETF / VETF01
- Conditions
- Vitiligo
- Keywords
- Phototherapy, Vitiligo scoring system
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituti Fisioterapici OspitalieriUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 5 Sep 2007 (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.
Background
Phototherapy UVB TL01 currently represents the first choice in treatment to induce the repigmentation of vitiligo spots. The problem though is that there are no systems or scales which enable an objective evaluation of the therapy, commonly known as percentage of repigmentation.
Recently, a European Task Force (VETF, Vitiligo European Task Force) of experts on vitiligo, within the European Society of Pigmentation, has proposed a gravity classification on the basis of three parameters/standards - extension, progression and the level of depigmentation - and used to classify patients in ten European centres. The aim of the trial is to validate the VETF scoring system set up in relation with the therapeutic answer to the standard treatment for vitiligo and phototherapy.
Leaving aside short term side effects, such as sunrush/erythema and sunburn, which are reversible and infrequent, the main problem with phototherapy is represented by the cumulative long term effects of ultraviolet rays. These can cause premature ageing of the skin (photoaging) and the appearance of skin cancer/neoplasia. Therefore the aim is to get the best results from phototherapy whilst limiting its length.
Aims of the trial:
- To validate the VETF scoring system. As phototherapy is currently the only universally accepted treatment for vitiligo, it seems logical to test the VETF scoring system first to evaluate the effectiveness of phototherapy.
- Secondly, the target of this multicentric trial is to compare the effectiveness of two different phototherapy protocols; a first protocol foresees non-stop treatment for 6 months; a second protocol foresees periods of interruption during the treatment. This will help to verify whether interrupting a cycle of phototherapy is useful or not.
This interruption might make the ultraviolet rays more effective 'stimulus on the melanocytes', and may also reduce long term damage caused by phototherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Genetic: Sequential phototherapyGroup A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment |
| B | Active comparator | Procedure: Continuous phototherapyGroup B: 6 months non-stop treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged between 18 and 60 years old
Key exclusion criteria (4 listed)
- Phototype I
- Previous treatment with any kind of phototherapy in the last 6 months.
- Patients with counter indications for PUVA or phototherapy (history of skin cancer, pregnancy, etc.).
- Acral vitiligo (only hands and feet are affected).
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 |
|---|---|---|
| Sequential phototherapyGroup A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment | Genetic | A |
| Continuous phototherapyGroup B: 6 months non-stop treatment. | Procedure or surgery | B |
Primary outcome
The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
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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.
Mauro Picardo, MD contact
Mauro Picardo, MD study chair
Istituto San Gallicano - Rome - Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sequential phototherapy and Continuous phototherapy in people with Vitiligo, run by Istituti Fisioterapici Ospitalieri at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 2 Jun 2010. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mauro Picardo, MD (picardo@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups. (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 2 Jun 2010.