E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Dermatitis Patients with Skin Lesions of Moderate Severity |
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E.1.1.1 | Medical condition in easily understood language |
a chronic inflammatory skin rash. |
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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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012438 |
E.1.2 | Term | Dermatitis atopic |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
The primary objective is to evaluate the efficacy of dermal 0.5% roflumilast cream formulation compared with vehicle on the reduction of atopic dermatitis lesions during 15 days of treatment in atopic dermatitis patients with skin lesions of moderate severity, using the modified local SCORAD. |
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E.2.2 | Secondary objectives of the trial |
To assess barrier function by measurement of transepidermal water loss (TEWL)
To evaluate effect on pruritus, by subjective assessment and recorded on a numeric scale ranging from 0 to 10
To evaluate the local and systemic safety of a dermal cream of 0.5% roflumilast as measured by rates of AEs relative to vehicle as well as changes in vital signs and clinical laboratory parameters |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects aged 18 to 65 with atopic dermatitis according to Hanifin and Rajka’s criteria, with lesional skin areas of moderate severity, characterized by a modified local SCORAD of at least 4, with an erythema score ≥2 and confirmed by a qualified investigator. Subjects must have a target lesion of approximately 20 cm2, suitable for topical treatment, and be willing to wash out from current active therapy for atopic dermatitis prior to Day 1. |
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E.4 | Principal exclusion criteria |
Subjects who have hypersensitivity to roflumilast or related compounds, a history of atopic dermatitis unresponsive or poorly responsive to topical treatments, a current skin complication such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated, have evidence of oozing at the target lesion, or have used any of the excluded medications within the time frames listed in Excluded Medications and Treatments and in the inclusion and exclusion criteria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change from baseline to Day 15 in modified local SCORAD (erythema, edema/papulation, oozing/crusts, excoriations, lichenification). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Change from baseline to Day 15 in TEWL values
Change from baseline to Day 15 in subjects’ assessment of pruritus on a numeric scale from 0 to 10 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 3 |
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 | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |