arrow band UV-B phototherapy and fluticasone proprionate versus narrow band UV-B phototherapy and placebo for the treatment of active vitiligo: a randomized double blind controlled trial - UVBVIT
- Conditions
- arrow band ultra violet B phototherapy is the gold standard for the treatment of vitiligo vulgaris. Ultra violet A and fluticasone proprionate (cutivate) together have shown significant better repigmentation than both treatments alone in a study by Westerhof et al in 1999. We expect that the combination of narrow band ultra violet B and fluticasone proprionate will have a significantly better result in terms of repigmentation for the treatment of vitiligo.
- Registration Number
- EUCTR2008-006903-22-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
i.Patients with active vitiligo, eligible for NB-UVB phototherapy;
ii.Subjects attending the outpatient department of the SNIP;
iii.Adult patients: = 18 years;
iv.Subject is willing and able to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
v.With a personal or a family history of skin cancer (non-melanoma skin cancer: first degree family members, melanoma: any family member)
vi.With a personal history of photosensitivity and/or phototoxicity disorders
vii.With skin type I (according to Fitzpatrick classification I-VI)
viii.Who are pregnant
ix.Who are taking medications known to cause photosensitivity and/or phototoxicity and chronic or very frequent use of any medication that can influence the UVB response (eg. tetracycline, retinoids, sulfonamids, psoralens, NSAID’s)
x.With other skin diseases that would impair evaluation of repigmentation, such as psoriasis and eczema.
xi. Who are not able to have 2 times weekly NB-UVB phototherapy
xii. With local immunosuppressive treatment or 6 weeks prior to enrolment. For these patients a washout period of 6 weeks will be required.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to evaluate the difference in clinical effects (onset and degree of repigmentation) of NB-UVB and fluticasone proprionate vs NB-UVB and placebo. ;Secondary Objective: N/A;Primary end point(s): Efficacy of narrow band ultra violet B and fluticasone proptionate compared to narrow band ultra violet B alone for the treatment of vitiligo
- Secondary Outcome Measures
Name Time Method