Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol

Phase 3

• Conditions: Vitiligo
• Interventions: Genetic: Sequential phototherapy; Procedure: Continuous phototherapy

• Registration Number: NCT00525395
• Lead Sponsor: Istituti Fisioterapici Ospitalieri

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:

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-01
• Last Update Posted: 2010-06-02
• Primary Completion: 2010-12
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Sequential phototherapy	Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
B	Continuous phototherapy	Group B: 6 months non-stop treatment.

Primary Outcome Measures

Name	Time	Method
The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups.	6 months

Trial Locations

Locations (1)

Istituto San Gallicano -; 🇮🇹 Rome, Italy