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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E.1.1.1 | Medical condition in easily understood language |
mild to moderate atopic dermatitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effectiveness of pimecrolimus cream 1% in the long-term management in mild to moderate atopic dermatitis in pediatric patients in a daily practice |
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E.2.2 | Secondary objectives of the trial |
•To monitor the safety of pimecrolimus cream 1% in the long-term management
• To evaluate quality of life of both parent and patient assessed by questionnaire.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Pediatric outpatients, male or female, age 3 months to 12 years old, with mild to moderate atopic dermatitis.
•Investigators Global Assessment (IGA) ≥ 1
•Written inform consent
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E.4 | Principal exclusion criteria |
•Concurrent diseases/conditions and history of other diseases/conditions
•Subjects who have active viral infections at the treatment site.
•Subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation).
•Subjects who present with clinical conditions other than AD that can interfere with the evaluation (e.g., generalized erythroderma such as the genetic condition, Netherton’s Syndrome, other skin conditions such as psoriasis, or skin malignancies such as squamous cell or basal cell carcinoma - please note that this does not exclude subjects who have a history of skin malignancies which have been previously treated, are in complete remission, and who are expected to be medically stable during the 12-month study period.).
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: (Primary) Number of days of TCS usage
Safety: Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, and the performance of a physical examination.
Quality of life: According to the Parent’s Index of Quality of Life Questionnaire -Atopic Dermatitis (PIQoL-AD) and the Children’s Dermatological Life Quality Index (CDLQI)
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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) |
Efficacy:(Secondary)
o IGA assessment
o F-IGA assessment
o Subject’s overall satisfaction
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.3 |
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 |
Mexico |
Venezuela, Bolivarian Republic of |
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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 |