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.

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

Study Description

Brief 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.

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
Vitiligo	Genetic: Sequential phototherapy Procedure: Continuous phototherapy	Phase 3

Study Design


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

Genetics Home Reference related topics: Vitiligo

MedlinePlus related topics: Vitiligo

Genetic and Rare Diseases Information Center resources: Hypomelanotic Disorder

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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.


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00525395

Contacts


Contact: Mauro Picardo, MD		picardo@ifo.it

Locations


Italy
Istituto San Gallicano -	Recruiting
Rome, Italy, 00100
Contact: Mauro Picardo, MD picardo@ifo.it

Sponsors and Collaborators

Istituti Fisioterapici Ospitalieri

Investigators


Study Chair:	Mauro Picardo, MD	Istituto San Gallicano - Rome - Italy

More Information


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

To Top