Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol

NCT00525395 | Unknown Phase 3 DMC

• 1 other identifier: VETF01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Vitiligo

Keywords

Phototherapy; Vitiligo scoring system

Outcome Measures

Primary Outcomes (1)

• The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups.

  6 months

Study Arms (2)

A

EXPERIMENTAL

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

Genetic: Sequential phototherapy

B

ACTIVE COMPARATOR

Group B: 6 months non-stop treatment.

Procedure: Continuous phototherapy

Interventions

Sequential phototherapy GENETIC

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

A

Continuous phototherapy PROCEDURE

Group B: 6 months non-stop treatment.

B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 60 years old

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituti Fisioterapici Ospitalieri: lead

Study Sites (1)

Istituto San Gallicano -

Rome, Rome, 00100, Italy

RECRUITING

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mauro Picardo, MD

  Istituto San Gallicano - Rome - Italy

  STUDY CHAIR

Central Study Contacts

Mauro Picardo, MD

CONTACT

picardo@ifo.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 2, 2010

Record last verified: 2010-06

Locations

IT (1)