- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00525395
Virus Early Transcription Factor (VETF) Multicenter Phototherapy Protocol (VETF)
Continuative vs Sequential Phototherapy in Non-segmental Vitiligo Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Mauro Picardo, MD
- Email: picardo@ifo.it
Study Locations
-
-
-
Rome, Italy, 00100
- Recruiting
- Istituto San Gallicano -
-
Contact:
- Mauro Picardo, MD
- Email: picardo@ifo.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A
Group A: 2 months treatment-1 month no treatment-2 months treatment-1 month no treatment
|
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.
|
Group B: 6 months non-stop treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of repigmentation on the target lesions will be evaluated at the end of each treatment in both groups.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Study Chair: Mauro Picardo, MD, Istituto San Gallicano - Rome - Italy
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VETF01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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