Seborrhoeic dermatitis (SD)
Conditions
Interventions
Trade Name: Elidel, creme
Product Name: Elidel Cream 1%
Pharmaceutical Form: Cream
INN or Proposed INN: Pimecrolimus
Current Sponsor code: ASM981
Concentration unit: % percent
Concentration type: equa
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: 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 ;Primary end point(s): Safety and tolerability | — |
Countries
Denmark
Outcome results
None listed