E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate Atopic Dermatitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003641 |
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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 demonstrate that pimecrolimus cream 1 % is superior to vehicle cream in time of improvement of pruritus, administered twice a day to both groups on the areas affected by AD, in patients between 2 – 11 years of age with mild-to-moderate AD. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy (IGA and EASI improvement) of Pimecrolimus cream 1 % administered b.i.d. over vehicle cream 1 %. - To evaluate the improvement of the sleep (when it is affected in the baseline) with Pimecrolimus cream 1 % treatment administered b.i.d. in regards of ASM981 vehicle cream. - To determine safety and tolerability of Pimecrolimus cream 1 % treatment.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Male or female - Age: between 2 – 11 years - Outpatients with diagnosis atopic dermatitis using diagnostic criteria of Williams and cols. - AD affecting ≥ 5% of Total Body Surface Area (estimated using the patient’s palm of the hand as approximately 1% TBSA) - Baseline Investigator’s Global Assessment score of 2 (mild) or 3 (moderate) - Baseline visit pruritus associated to atopic dermatitis - Patients or patient’s legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).
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E.4 | Principal exclusion criteria |
- Who are using a topical medication (prescription or OTC medications) for pruritus relief within 7 days of study start - Who are taking any systemic (oral/IM/IV) medication known to have a sedating side affect or known to affect pruritus such as tranquilizers, hypnotic agents, anxiolytics (including oral doxepin), tricyclic antidepressants, corticosteriods or antihistamines (sedating or non-sedating) within 1 week prior to first application of study medication. - Phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on atopic dermatitis within 1 month prior to first application of study medication. - Topical tacrolimus ointment (Protopic) or ASM981 (Pimecrolimus) cream within 4 weeks prior to first application of study medication regardless of whether the medication was given as an investigational drug. - Topical therapy (e.g. tar, topical corticosteroid) known or suspected to have a therapeutic effect on atopic dermatitis within 7 days prior to first application of study medication - Systemic antibiotics within 1 week prior to first application of study medication - Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or a history of malignant disease - Concurrent skin disease (e.g., acne) of such severity in the study area that it could interfere with the evaluation - Atopic dermatitis triggered by a known irritant/allergen that is unavoidable - Active bacterial, viral or fungal infections that require treatment with a prohibited medication - Active infection at the site(s) of treatment - Atopic dermatitis that, in the investigator’s opinion, requires systemic therapy and will not be controlled with study medication - Investigational drugs within 8 weeks prior to first application of study medication or use of other investigational drugs during the course of this study - Known hypersensitivity to any ingredient of ASM981 cream 1% (see the Investigators Brochure)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is to demonstrate that the therapeutic efficacy of Pimecrolimus cream 1 % administered b.i.d. is superior to ASM981 vehicle cream administered b.i.d. evaluating the time to pruritus improvement
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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 | 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 | Information not present in EudraCT |
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 | 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.8.5 | The trial involves multiple Member States | No |
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 | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 9 |