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] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
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 |
To evaluate the efficacy of tacrolimus ointment at 0.03% in Brazilian pediatric patients with mild, moderate and severe atopic dermatitis through the Physician’s Global Assessment of Clinical Response |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the tacrolimus activity in reducing the area and severity of atopic dermatitis through the EASI (eczema area and severity index) score;
- To evaluate the tacrolimus action in reducing the percentage of body surface area (% BSA) affected by atopic dermatitis;
- To analyze the effect of tacrolimus on the pruritus from the patient with atopic dermatitis;
- To evaluate the safety profile of tacrolimus ointment at 0.03% in Brazilian pediatric patients with atopic dermatitis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Children 2-10 years of age;
- Mild to severe atopic dermatitis. |
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E.4 | Principal exclusion criteria |
- Skin disorder other than atopic dermatitis;
- Previous treatment with tacrolimus ointment in a clinical study;
- Known diagnosis or history of cancer, including skin cancer, or human immunodeficiency virus (HIV);
- Clinically infected atopic dermatitis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical response (>90% improvement in areas defined for treatment at baseline) according to Physician’s Global Assessment of Clinical Response Scale |
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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 in percent of body surface area (BSA) affected compared to Baseline
- Change in Eczema Area and Severity Index (EASI) score compared to Baseline
- Change in the scale of subject's assessment of pruritus score compared to Baseline
- Percentage of participants with adverse events |
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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 | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |