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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
Sponsor:
Information provided by:
Istituti Fisioterapici Ospitalieri

September 4, 2007
September 5, 2007
June 2, 2010
April 2007
December 2010   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00525395 on ClinicalTrials.gov Archive Site
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Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol
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.

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:

  1. 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.
  2. 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Vitiligo
  • Genetic: Sequential phototherapy
    Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
  • Procedure: Continuous phototherapy
    Group B: 6 months non-stop treatment.
  • Experimental: A
    Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
    Intervention: Genetic: Sequential phototherapy
  • Active Comparator: B
    Group B: 6 months non-stop treatment.
    Intervention: Procedure: Continuous phototherapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Not Provided
June 2011
December 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00525395
VETF01
Yes
Not Provided
Not Provided
Dott. Mauro Picardo, Istituto San Gallicano - Roma
Istituti Fisioterapici Ospitalieri
Not Provided
Study Chair: Mauro Picardo, MD Istituto San Gallicano - Rome - Italy
Istituti Fisioterapici Ospitalieri
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP