| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | atopic dermatitis (atopic eczema) | |
| 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 | The primary objective for this study is to demonstrate the relative efficacy of pimecrolimus cream 1% applied twice daily (b.i.d.) versus once daily (o.d.) in preventing the progression to disease “relapse” (defined as exacerbation of disease to the level where a topical corticosteroid and/or alternative or additional therapy is required [confirmed by IGA score of 3 or more and a pruritus score of 2 or 3).
| |
| E.2.2 | Secondary objectives of the trial | The safety and tolerability of pimecrolimus cream 1% when applied either b.i.d. or o.d.
Disease-free time for subjects who achieve “remission” of AD during the run-in phase to the time of “recurrence” of AD during the Maintenance period (from randomization to 1st day of double-blind study drug). | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | Inclusion criteria - Screening/Run-In Period
• age 2 years through age 17 years of age
• IGA score of 2, 3, or 4 (mild, moderate, or severe AD) affecting ≥5% TBSA
(estimated using the subject’s palm of the hand as approximately 1% TBSA)
• outpatients
• subject (or primary caregiver) has been informed of the study procedures and
requirements and has signed the approved informed consent form (and patient assent form if applicable)
Inclusion criteria - Double-blind Maintenance treatment period
• Achieve complete remission of active disease (no signs or symptoms of AD) without
incidence of “relapse” by the end of 6-week Run-In period (may be earlier), or who
achieve “disease improvement” (decrease in IGA score by 1 full point confirmed by
the investigator) without incidence of relapse at the end of the 6-week Run-In period. | |
| E.4 | Principal exclusion criteria | Exclusion criteria - Screening/Run-In period
• subjects who applied topical therapy (e.g. tar, topical corticosteroids, pimecrolimus
(Elidel®) or tacrolimus (Protopic®) within 2 weeks prior to Screening
• subjects who received phototherapy (e.g. UVB, PUVA, Narrow Band) within 4 weeks
of Screening
• subjects who received any systemic immunosuppressant (e.g. Neoral®,
Cyclosporine®, Prograf®, methotrexate, etc.) within 4 weeks of Screening
• subjects who received systemic steroids (e.g. oral, intravenous, intra-articular, rectal) for any reason within 4 weeks of Screening
• females who are pregnant or breast-feeding, or planning to become pregnant during the study
• females who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (required during study and up to 4 weeks post-treatment). A “medically approved” method of contraception may include abstinence at the discretion of the investigator. (A negative urine pregnancy test is required for all females of childbearing potential at Screening)
• subjects who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich
syndrome) or have a history of malignancy (includes basal cell carcinoma, squamous
cell carcinoma, melanoma)
• subjects with open skin infections (bacterial, viral or fungal) if at the application site. Subjects will HSV (common cold sores) are allowed to participate in the study (if not at the application site).
• subjects who have head lice or scabies
• subjects who present with clinical conditions other than AD that may interfere with
the evaluation (e.g., generalized erythroderma, acne, Netherton’s Syndrome,
psoriasis)
• subjects that require systemic therapy for the treatment of atopic dermatitis
subjects with poor or no clinical response to tacrolimus ointment (Protopic®) or
pimecrolimus cream 1%
• subjects who used any experimental or investigational drug or therapy within 6 weeks prior to Screening
• subjects who intend to use experimental or investigational drug therapy during the
course of this study
• subjects with known hypersensitivity to pimecrolimus 1% or related drugs (see
Investigator’s Brochure)
• subjects who are non-compliant with general medical treatment, or are known to miss appointments, or don’t intend to comply with the protocol for the duration of the
study
• drug abuse, mental dysfunction, or other factors limiting the subject’s ability to
cooperate fully with study-related procedures
• subjects known to be unreliable or may be unable to complete the study
• Any condition or prior/present treatment that would render the subject ineligible for
the study
Exclusion criteria - Double-blind Maintenance treatment period
• subjects who experienced a “relapse” during the Run-In period
• subjects who applied topical corticosteroids or any alternative or additional therapy
for the treatment of AD during the Run-In period
• subjects with active skin infections (bacterial, viral or fungal) except common cold
sores (HSV) at the application site
• subjects who failed to record study medication use (and non use) and dosing regimen during the Run-In period
• subjects who failed to apply open label study drug twice daily until “disease
remission” or end of the 6 week Run-In period (whichever occurred first)
• subjects who failed to record concomitant medications during the Run-In period
• failure to return open-label study drug (used, partially used, and unused tubes) at the time double-blind study drug is dispensed. In order to avoid medication error, all
open label study drug must be returned to the site before starting the Maintenance
period (a window of 48 hours to return open-label medication is allowed) | |
| E.5 End points |
| E.5.1 | Primary end point(s) | Primary efficacy
The primary efficacy variable will be time to disease “relapse” as determined from the time of entry into the Maintenance period (randomization, visit 2) to the time of confirmed “relapse” by the investigator (USV). The time to disease “relapse” will be assessed only during the double-blind Maintenance period of the study. | |
| 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 | 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 | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Information not present in EudraCT |
| 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 | |
| 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 | |
| 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 | |
| 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 | 0 |
