E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Narrow 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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal exclusion criteria |
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.
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |