E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammatory seborrhoeic dermatitis of the scalp in adult |
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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 |
To assess the superiority of 0.050% betamethasone (dipropionate) shampoo (V0071 GM 01A) in comparison to ketoconazole 2% (foaming) gel on inflammatory seborrhoeic dermatitis of the scalp. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of 0.050% betamethasone (dipropionate) shampoo (V0071 GM 01A) on inflammatory seborrhoeic dermatitis of the scalp.
To determine local and global tolerance of 0.050% betamethasone (dipropionate) shampoo (V0071 GM 01A) and ketoconazole 2% (foaming) gel. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Will be eligible subjects who meet the following criteria : - Patient aged above 18 years and less than 65 years, - patients with an inflammatory seborrhoeic dermatitis of the scalp defined as an involvement of at least 15% of the scalp area, - patients with inflammatory seborrhoeic dermatitis bilateral lesions of the scalp combining area on each half head with at least a 5 point sum score (erythema + scaling) on a 8 point grading score, and no more than 1 point difference between each area score, - patients with dandruff on both sides of the head, - patients who agree to stop application of topical product on the scalp (drug and/or cosmetics), - negative urine pregnancy test at inclusion for woman of child bearing potential and using an efficient contraceptive (implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner; see appendix 2 -CPMP guidelines) for at least 2 months before the study and one month after the end of the study, - patient accepting to participate to the study and able to understand and sign an approved Informed Consent Form, - patient able to understand the protocol and to come to the control visits, - patient who, in the judgement of the investigator is likely to be compliant during the study, - registered with a social security or health insurance system.
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E.4 | Principal exclusion criteria |
Will not be included subjects who have one of the following criteria :
* Criteria related to pathologies : - Patients with psoriasis of the scalp, - patients with any underlying skin disease which might interfere the seborrhoeic dermatitis evaluation.
* Criteria related to treatments : - Patient with history of hypersensitivity to betamethasone (dipropionate) or ketoconazole or any ingredient of each product, - treatment with systemic antifungus and/or corticosteroids and/or retinoid and/or immunosuppressive and/or anti-infective drugs within two weeks before the inclusion visit (except inhaled steroid), - treatment with systemic lithium.
* Criteria related to the population : - History of known HIV positive serology, - medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug, - female who is pregnant or breast feeding or not using contraception, or planning to become pregnant, - participation to an other clinical trial in the previous month or during the study, - patient who, is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent, - patient who, in the judgement of the investigator, is not likely to be compliant during the study, - patient who has forfeited his/her freedom by administrative or legal decision, or who is under guardianship, - patient who has received more than 4500 Euros as indemnity for participating in clinical studies within the previous12 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
Evolution of the clinical global sum score on each half head (i.e.=erythema +scaling) at D14 |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
investigator masked in initiation therapy |
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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
| 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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the end of the study is the date of 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 | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |