E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
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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 compare subject s overall preference between Clobetasol propionate shampoo 0.05 and three other topical corticosteroids in the treatment of moderate to severe scalp psoriasis. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male or female subjects, 18 years of age or older, 2. Subjects with moderate to severe scalp psoriasis defined as global severity score of at least 3 on a 6-point scale , 3. Female subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly effective method of contraception during the study oral contraception, IUD, systemic injectable or patch contraception, strict abstinence or partner had a vasectomy, 4. Females of non-childbearing potential, i.e., premenses, post-menopausal absence of menstrual bleeding for 2 years , hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, are not required to have a UPT at the beginning of the study, 5. Subjects who signed written informed consent prior to any study procedures, 6.Subjects willing and capable of cooperating to the extent and degree required by the protocol |
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E.4 | Principal exclusion criteria |
1. Subjects who need systemic treatment for their body psoriasis, 2. Subjects who are at risk in terms of precautions, warnings and contra-indication see package inserts and/or Investigator Brochure , 3. Female subjects who are pregnant, nursing or planning a pregnancy during the study, 4. Subjects who have participated in another investigational drug or device research study within 30 days of enrolment, 5. Subjects with a washout period for topical treatment s on the scalp less than Corticosteroids 2 weeks All other anti-psoriasis medications including, but not restricted to vitamin D derivatives, retinoids, salicylic acid, urea, coal tar and anthralin 2 weeks UV-light therapy 2 weeks 6. Subjects with a washout period for systemic treatment s less than PUVA therapy 4 weeks Biological therapies e.g. alefacept, efalizumab, etanercept, infliximab 12 weeks Treatments other than biologicals with a possible efficacy on psoriasis such as acitretin, isotretinoin, methotrexate, cyclosporine, corticosteroid, hydroxycarbamide, azathioprine 4 weeks Treatment known to worsen psoriasis such as lithium, beta-blockers, antimalarials, ACE inhibitors 2 weeks NOTE unless subjects have been on treatment for at least 6 months and their psoriasis considered stable at study inclusion 7. Subjects with an history of adverse response either severe side-effects or corticoresistance to topical or systemic steroid therapy, 8. Subjects who plan to have intensive UV sun exposure during the study mountain sports, UV radiation, sunbathing, etc , 9.Subject with a condition or who is in a situation which, in the investigator s opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject s participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
primary variable on PP and ITT population to be analysed on this study will be subjects overall preference at the end of period II |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |