Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Istituti Fisioterapici Ospitalieri.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Istituti Fisioterapici Ospitalieri
ClinicalTrials.gov Identifier:
NCT00525395
First received: September 4, 2007
Last updated: June 1, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Vitiligo
Genetic: Sequential phototherapy
Procedure: Continuous phototherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuative vs Sequential Phototherapy in Non-segmental Vitiligo Patients

Resource links provided by NLM:


Further study details as provided by Istituti Fisioterapici Ospitalieri:

Primary Outcome Measures:
  • The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
Genetic: Sequential phototherapy
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
Active Comparator: B
Group B: 6 months non-stop treatment.
Procedure: Continuous phototherapy
Group B: 6 months non-stop treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525395

Contacts
Contact: Mauro Picardo, MD picardo@ifo.it

Locations
Italy
Istituto San Gallicano - Recruiting
Rome, Italy, 00100
Contact: Mauro Picardo, MD       picardo@ifo.it   
Sponsors and Collaborators
Istituti Fisioterapici Ospitalieri
Investigators
Study Chair: Mauro Picardo, MD Istituto San Gallicano - Rome - Italy
  More Information

No publications provided

Responsible Party: Dott. Mauro Picardo, Istituto San Gallicano - Roma
ClinicalTrials.gov Identifier: NCT00525395     History of Changes
Other Study ID Numbers: VETF01
Study First Received: September 4, 2007
Last Updated: June 1, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Istituti Fisioterapici Ospitalieri:
Phototherapy
Vitiligo scoring system

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014