E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seborrhoeic dermatitis (SD) |
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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 safety and tolerability of long term intermittent treatment with pimecrolimus 1% cream in patients with SD with particular attention to the occurrence of non-melanoma skin cancer (NMSC). |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of pimecrolimus 1% cream in patients with SD, with respect to facial Investigator Global assessment (IGA), non-facial IGA, time to facial clearance, time to whole body clearance, time to facial recurrence, time to whole body recurrence.
Exploratory objectives :
To explore: • the incidence rate of SD recurrence during the treatment with pimecrolimus cream, • the drug consumption per patient: per episode and over the entire study period, • the health-related quality of life questionnaire (DLQI).
Photographic documentation to set up a visual scale for the phase III studies
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Male or female patients aged 12 years or older • Patients with mild, moderate or severe seborrhoeic dermatitis with facial involvement (facial IGA 1-3) • Patients who have had at least 3 exacerbations of seborrhoeic dermatitis requiring a medication on the face during the last 12 months • Written informed consent (by a legal guardian for patients below the age of consent)
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E.4 | Principal exclusion criteria |
Concurrent diseases/conditions and history of other diseases/conditions
• Presence of any concurrent dermatological condition in the affected area that according to the investigator may interfere with the clinical evaluation (such as: acne, rosacea, pityriasis versicolor, psoriasis, active skin infection). • Known HIV infection or history of immunocompromised status (e.g. lymphoma, AIDS, Wiskott-Aldrich syndrome) or known immunosuppression. • History or presence of malignancy of any organ system or lymphoproliferative diseases.
Other medications / therapies
• Application of topical corticosteroids or other topical medication (including non-prescription products, except for medicated shampoos) known to influence seborrhoeic dermatitis (such as: antifungals, lithium succinate/gluconate, calcipotriol, tacrolimus, pimecrolimus) within 7 days prior to the first application of study medication. • Administration of any systemic immunosuppressor (such as: systemic corticosteroids, systemic tacrolimus, cyclosporine) or phototherapy (e.g. UVB, PUVA) or any other systemic medication (including non-prescription products) known or suspected to have a positive or negative effect on seborrhoeic dermatitis (such as: oral antifungals, lithium salts) within 30 days prior to drug application. Investigational drug / therapy use • Use of any investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. Ingredient hypersensitivity • Known serious adverse reactions or hypersensitivity to calcineurin inhibitors, or any ingredients of pimecrolimus cream.
Compliance / reliability / investigator’s judgment
• Patients who are - in the opinion of the investigator - known to be unreliable, or non-compliant, or with any condition or prior or present treatment (including cosmetic products) rendering the patient ineligible for the study. • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml) • Women of child-bearing potential (WOCBP), UNLESS meeting the protocol definition of post-menopausal, OR are using one or more of the acceptable methods of contraception described in the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
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 | 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) | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |