Working... Menu

Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol (VETF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Istituti Fisioterapici Ospitalieri

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Vitiligo Genetic: Sequential phototherapy Procedure: Continuous phototherapy Phase 3

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arm Intervention/treatment
Experimental: A
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
Genetic: Sequential phototherapy
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment

Active Comparator: B
Group B: 6 months non-stop treatment.
Procedure: Continuous phototherapy
Group B: 6 months non-stop treatment.

Primary Outcome Measures :
  1. The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups. [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00525395

Layout table for location contacts
Contact: Mauro Picardo, MD

Layout table for location information
Istituto San Gallicano - Recruiting
Rome, Italy, 00100
Contact: Mauro Picardo, MD   
Sponsors and Collaborators
Istituti Fisioterapici Ospitalieri
Layout table for investigator information
Study Chair: Mauro Picardo, MD Istituto San Gallicano - Rome - Italy

Layout table for additonal information
Responsible Party: Dott. Mauro Picardo, Istituto San Gallicano - Roma 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:
Vitiligo scoring system

Additional relevant MeSH terms:
Layout table for MeSH terms
Pigmentation Disorders
Skin Diseases