Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol

Vitiligo Clinical Trial

— VETF  

Official title:

Continuative vs Sequential Phototherapy in Non-segmental Vitiligo Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00525395
• Other study ID #: VETF01
• Status: Recruiting
• Phase: Phase 3
• First received: September 4, 2007
• Last updated: June 1, 2010
• Start date: April 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: Istituti Fisioterapici Ospitalieri
• Contact: Mauro Picardo, MD
• Email: picardo[@]ifo.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto San Gallicano -	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Fisioterapici Ospitalieri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups.		6 months	No