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Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol (VETF)

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Sequential phototherapy
Continuous phototherapy
Sponsored by
Istituti Fisioterapici Ospitalieri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Phototherapy, Vitiligo scoring system

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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).

Sites / Locations

  • Istituto San Gallicano -Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

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

Group B: 6 months non-stop treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 4, 2007
Last Updated
June 1, 2010
Sponsor
Istituti Fisioterapici Ospitalieri
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1. Study Identification

Unique Protocol Identification Number
NCT00525395
Brief Title
Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol
Acronym
VETF
Official Title
Continuative vs Sequential Phototherapy in Non-segmental Vitiligo Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Istituti Fisioterapici Ospitalieri

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Phototherapy, Vitiligo scoring system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
Arm Title
B
Arm Type
Active Comparator
Arm Description
Group B: 6 months non-stop treatment.
Intervention Type
Genetic
Intervention Name(s)
Sequential phototherapy
Intervention Description
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
Intervention Type
Procedure
Intervention Name(s)
Continuous phototherapy
Intervention Description
Group B: 6 months non-stop treatment.
Primary Outcome Measure Information:
Title
The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mauro Picardo, MD
Email
picardo@ifo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Picardo, MD
Organizational Affiliation
Istituto San Gallicano - Rome - Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Istituto San Gallicano -
City
Rome
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mauro Picardo, MD
Email
picardo@ifo.it

12. IPD Sharing Statement

Learn more about this trial

Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol

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