E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
Assessment of efficacy and safety of a new methylprednisolone aceponate 0.1% cream in comparison with the approved preparation Advantan 0.1% cream and the underlying vehicle in patients with mild to moderate atopic dermatitis |
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E.2.2 | Secondary objectives of the trial |
• Percent change of Eczema Area and Severity Index Score (EASI Score) between visits • Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT) • Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT) • Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT) • Patient´s assessment of severity of pruritus
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Women, men and children/adolescents of both sexes ≥ 6 years of age • Written consent to study participation after patient information by the investigator • In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and child/adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator • Acute flare of atopic dermatitis according to the Investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate)) • Affected body surface (BSA) between at least 10% and not more than 40% • For women of childbearing potential: Application of an established highly efficient contraceptive method during the whole study • For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start
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E.4 | Principal exclusion criteria |
• Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion • Any topical treatment (e.g. topical immunomodulators such as tacrolimus ointment, pimecrolimus cream, topical antibiotics, topical glucocorticoids, other topical anti-inflammatory medication) or physical therapy (e.g. UV radiation) of the atopic dermatitis in the test area 2 weeks prior to study inclusion • Presence of tuberculous or syphilitic processes in the treatment area • Presence of viral infections (such as herpes or varicella), rosacea, perioral dermatitis, ulcera, acne vulgaris, atrophic skin diseases and vaccination skin reactions in the area to be treated. • Presence of bacterial and/or mycotic skin diseases in the treatment area • Current diagnosis of glaucoma or cataract • Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication • Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations • Severe acute or chronic concomitant disease with severe impairment of the general condition • Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible • Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data • Reasonable doubt concerning the co-operation of the patient • Participation in another clinical study within the last 30 days prior to inclusion in this study • Participation in this study at an earlier date • Women with existing or intended pregnancy or during lactation
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the percent change from baseline (Visit 1) to Visit 4 (EoT) assessed by Eczema Area and Severity Index Score (EASI Score) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Start of therapy (Day 0) and end of therapy (Visit 4) |
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E.5.2 | Secondary end point(s) |
• Percent change of Eczema Area and Severity Index Score (EASI Score) between baseline (Visit 1) and Visit 2 and Visit 3 • Percent change of the total affected body surface area (BSA) between baseline (Visit 1) and Visit 2, Visit 3 and Visit 4 • Change of the Investigator’s Global Assessment (IGA) between baseline (Visit 1) and Visit 2, Visit 3 and Visit 4 • Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT) • Patient´s assessment of severity of pruritus at visits (Visit 1, Visit 2, Visit 3 and Visit 4)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Depends on the secondary endpoint, see E.5.2 above |
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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 | Yes |
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) | No |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 15 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |