| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Seborrhoeic Dermatitis (SD) | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 | | E.1.2 | Level | LLT | | E.1.2 | Classification code | 10039793 | | E.1.2 | Term | Seborrhoeic dermatitis | |
| 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 | Main objectives
For Stage A the primary objective is to evaluate the efficacy of pimecrolimus cream in patients with seborrhoeic dermatitis compared to vehicle, assessed by overall clearance (overall IGA of 0 = clear) after one, two and three weeks of maximum treatment. One of these assessment timepoints will be selected for the final analysis of the primary endpoint (overall clearance).
For the entire trial the primary objective is to demonstrate the efficacy of pimecrolimus cream in patients with seborrhoeic dermatitis compared to vehicle, assessed by overall clearance (overall IGA of 0 = clear) at the assessment timepoint selected in the interim analysis after Stage A. | |
| E.2.2 | Secondary objectives of the trial | Efficacy:
To demonstrate the efficacy of pimecrolimus cream in patients with seborrhoeic dermatitis compared to vehicle with respect to
- facial clearance
- time to overall clearance
- time to facial clearance
- change in presence of pruritus
at the assessment timepoint selected in the interim analysis after Stage A.
To evaluate the efficacy of pimecrolimus cream in patients with seborrhoeic dermatitis compared to vehicle with respect to
- facial clearance and overall clearance at at least one visit during the trial
- facial and non-facial severity of lesional erythema and scaling at all assessment timepoints
- overall clearance throughout the trial
- time to relapse.
Safety:
To evaluate safety of pimecrolimus cream in patients with seborrhoeic dermatitis 12
years of age and older.
Exploratory Objectives:
- To compare amount of study drug per patient per episode
- To compare Health-related Quality of Life
| |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | - Male or female patients aged 18 years or older
- Patients, who have
- mild, moderate or severe seborrhoeic dermatitis with (overall IGA 1-3) and
- at least mild lesional erythema and at least mild scaling of non-scalp skin
- Written informed consent (by a legal guardian for patients below the age of consent) | |
| E.4 | Principal exclusion criteria | - Patients who have participated in Stage A cannot be recruited in Stage B.
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, lupus erythematosus, scleroderma, 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 or pre-malignant skin condition (such as actinic keratosis).
Other medications / therapies
- Application of topical corticosteroids or other topical medication (including nonprescription products or medicated shampoos) known to influence seborrhoeic dermatitis (such as antifungals, lithium succinate/gluconate, calcipotriol/calcipotriene, tacrolimus, pimecrolimus) within 7 days prior to the first application of study medication.
- Administration of any systemic immunosuppressant (such as systemic corticosteroids, systemic tacrolimus, cyclosporine) or phototherapy (e.g. UVB, PUVA within 30 days or 5 half-lives of enrollment, whichever is longer, prior to drug application.
- Administration of any 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 or 5 half-lives of enrollment, whichever is longer, prior to drug application.
Investigational drug / therapy use
- Use of any investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer.
- Ingredient hypersensitivity
- Known serious adverse reactions or hypersensitivity to pimecrolimus, 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 noncompliant, 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), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS
1) Patients meet the following definition of post-menopausal:
• 12 months of natural (spontaneous) amenorrhea
• 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m
• 6 weeks post surgical bilateral oophorectomy with or without hysterectomy
or
2) Patients are using one or more of the following acceptable methods of contraception:
• Surgical sterilization (e.g., bilateral tubal ligation, hysterectomy)
• Hormonal contraception (implantable, patch, oral)
• Double-barrier methods (any double combination of: male or female condom with
spermicidal gel, diaphragm, sponge, cervical cap)
• Any combination of IUD and a barrier method.
Since the known reproductive and developmental toxicity profile of pimecrolimus is low, acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study until study completion. Any female aged 12 years and above is to be treated as a WOCBP. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | |
| 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 | 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) | Yes |
| 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| 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 | Yes |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 12 |
| 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 | |
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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 | |
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
