E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 measure the blood concentrations of pimecrolimus after single and repeated doses of Elidel (pimecrolimus) Cream 1% when applied twice daily for 3 weeks on the whole lesional skin in patients with moderate or severe seborrheic dermatitis (SD). |
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E.2.2 | Secondary objectives of the trial |
•To explore the topical and systemic safety and tolerability of Elidel Cream 1% when applied twice daily for 3 weeks on the lesional skin of patients with moderate or severe SD •To explore the efficacy of Elidel Cream 1% in patients with SD.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Male and/or female subjects from 12 to 18 years of age inclusive (Cohort A), above 18 to 50 years of age inclusive (Cohort B) and above 50 years of age (Cohort C).
2.Male and female patients with a diagnosis of seborrheic dermatitis. At screening and baseline, patients must have a moderate or severe SD assessed by a score of ≥ 3 to the facial Investigator’s Global Assessment (IGA, Table 3-1). The SD will have to involve at least 5% of the Body Surface Area as determined by the Rule of Nine (Appendix 2). SD will be present in 3 areas of predilection (scalp, face, chest, intertriginous areas)
3.Except for SD, patients must be in good health as determined by past medical history, physical examination, vital signs and laboratory tests at screening.
4.Female subjects of child bearing potential must be using a double-barrier local contraception (i.e. intra-uterine device plus condom, or spermicidal gel plus condom, diaphragm plus spermicidal gel) or must have been surgically sterilized at least 6 months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion. Menopause will be confirmed by a plasma 17β-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L.
5.Adult patients must weigh at least 50 kg to participate in this study. Adolescent under 18 should have a body weight ≥10th percentile for age.
6.Vital signs (after 3 minutes resting measured in the supine position) which are within the following ranges: oral body temperature between 35.0-37.5 °C systolic blood pressure, 90-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 90 bpm
7.Subjects able to provide written informed consent prior to study participation. For patients below 18 years old, parents should be informed on the study procedures and provide their written informed consent too. Subject information and consent forms generated by the investigator must be approved by the sponsor prior to submission to the Ethics Committee (EC)/Institutional Review Board (IRB). A copy of the subject information and consent forms approved by the EC/IRB must be forwarded to the sponsor prior to study initiation.
8.Subjects able to communicate well with the investigator and comply with the requirements of the study.
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E.4 | Principal exclusion criteria |
1.Patients with atopic dermatitis, Netherton’s syndrome or psoriasis. 2.Clinically significant findings during the physical examination (except seborrheic dermatitis), or laboratory abnormalities. 3.Symptoms of a significant clinical illness other than SD in the three-week period preceding the entry in the study. 4.Presence of any viral or fungal or bacterial skin infection. 5.Patients with known serious adverse reactions or hypersensitivity to pimecrolimus, tacrolimus, macrolactam or to any of the excipients (see section 3.3.1) of the study medication. 6.Women who are pregnant or breastfeeding. Female adolescents who have reached menarche and do not use double barrier contraception during and at least until 4 weeks after the end of treatment. 7.Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. 8.Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing. 9.History of cancer, skin malignancy or lymphoproliferative disorders. 10.History of immunocompromise, including a positive HIV (ELISA and Western blot) test result. 11.A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. 12.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following: •clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin. SGPT will have to be strictly within the normal range before inclusion, GGT and alkaline phosphatase must not exceed twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL). •history or presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria); •polymorphonuclears <1500/µL or platelets <100’000/µL at inclusion. 13.Use of any prescription drug or over-the-counter (OTC) medication within 2 weeks prior to dosing. Paracetamol is acceptable, but must be documented in the Concomitant medications / Significant non-drug therapies page of the CRF. 14.Use of systemic corticosteroids (i.e. oral, intravenous, intra-articular, rectal) within four (4) weeks prior to baseline. 15.Phototherapy within four (4) weeks prior to baseline. 16.Topical therapy (e.g. tar, topical corticosteroids, topical anti-fungals,) within 3 days prior to baseline, with the exception of emollients. Topical tacrolimus within 2 weeks prior to baseline. 17.Treatment with nephrotoxic drugs within two (2) weeks prior to baseline (aminoglycosides, amphotericin B, colchicine). 18.Treatment with any CYP3A4 inhibitors or inducers within two (2) weeks prior to baseline and during the study course.
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetic/pharmacodynamic endpoints to measure blood levels of pimecrolimus |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
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) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |