An open-label study to investigate blood concentrations, safety, tolerability and efficacy of Elidel® Cream 1% in patients with moderate or severe seborrheic dermatitis treated topically for 3 weeks. - M2308

• Register: EUCTR
• Last refreshed on: 28 January 2013
• Main ID: EUCTR2004-004275-11-DE
• Date of registration: 14/09/2005
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services AG
• Public title: An open-label study to investigate blood concentrations, safety, tolerability and efficacy of Elidel® Cream 1% in patients with moderate or severe seborrheic dermatitis treated topically for 3 weeks. - M2308
• Scientific title: An open-label study to investigate blood concentrations, safety, tolerability and efficacy of Elidel® Cream 1% in patients with moderate or severe seborrheic dermatitis treated topically for 3 weeks. - M2308
• Date of first enrolment: 25/03/2005
• Target sample size: 22
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004275-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

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 17ß-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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Seborrheic dermatitis

Intervention(s)

Trade Name: Elidel 1% Creme
Product Name: pimecrolimus
Product Code: ASM981
Pharmaceutical Form: Cream
INN or Proposed INN: pimecrolimus
CAS Number: 137071-32-0
Current Sponsor code: ASM981
Concentration unit: % percent
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)

Primary end point(s): Pharmacokinetic/pharmacodynamic endpoints to measure blood levels of pimecrolimus

Secondary Objective: •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.

Main Objective: •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).

Secondary ID(s)

Not applicable

CASM981M2308