Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol (VETF)
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ClinicalTrials.gov Identifier: NCT00525395 |
Recruitment Status
: Unknown
Verified June 2010 by Istituti Fisioterapici Ospitalieri.
Recruitment status was: Recruiting
First Posted
: September 5, 2007
Last Update Posted
: June 2, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
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Vitiligo | Genetic: Sequential phototherapy Procedure: Continuous phototherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Continuative vs Sequential Phototherapy in Non-segmental Vitiligo Patients |
Study Start Date : | April 2007 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
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Genetic: Sequential phototherapy
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
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Active Comparator: B
Group B: 6 months non-stop treatment.
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Procedure: Continuous phototherapy
Group B: 6 months non-stop treatment.
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- The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups. [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged between 18 and 60 years old
Exclusion Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525395
Contact: Mauro Picardo, MD | picardo@ifo.it |
Italy | |
Istituto San Gallicano - | Recruiting |
Rome, Italy, 00100 | |
Contact: Mauro Picardo, MD picardo@ifo.it |
Study Chair: | Mauro Picardo, MD | Istituto San Gallicano - Rome - Italy |
Responsible Party: | Dott. Mauro Picardo, Istituto San Gallicano - Roma |
ClinicalTrials.gov Identifier: | NCT00525395 History of Changes |
Other Study ID Numbers: |
VETF01 |
First Posted: | September 5, 2007 Key Record Dates |
Last Update Posted: | June 2, 2010 |
Last Verified: | June 2010 |
Keywords provided by Istituti Fisioterapici Ospitalieri:
Phototherapy Vitiligo scoring system |
Additional relevant MeSH terms:
Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases |