Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol

Istituti Fisioterapici Ospitalieri

Status and phase: Unknown; Phase 3

Conditions: Vitiligo

Treatments: Procedure: Continuous phototherapy; Genetic: Sequential phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00525395

VETF01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A

Experimental group

Description:

Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment

Treatment:

Genetic: Sequential phototherapy

B

Active Comparator group

Description:

Group B: 6 months non-stop treatment.

Treatment:

Procedure: Continuous phototherapy