Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol
Recruitment status was Recruiting
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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:
- 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.
| 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 |
- 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 |
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| Contact: Mauro Picardo, MD | picardo@ifo.it |
| Italy | |
| Istituto San Gallicano - | Recruiting |
| Rome, Italy, 00100 | |
| Contact: Mauro Picardo, MD picardo@ifo.it | |
| 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 June 17, 2013