E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Dermatitis |
Dermatite Atopica |
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E.1.1.1 | Medical condition in easily understood language |
Chronic inflammatory disease of the skin |
Malattia infiammatoria cronica della pelle |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physical Phenomena [G01] |
MedDRA Classification |
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 |
Objective of the study is to evaluate the effects of treatment with methylprednisolone aceponate and Bepanthenol Sensiderm® with two different application modalities on the AD clinical course in pediatric patients with mild to moderate AD. |
Valutare gli effetti del trattamento concomitante con una crema a base di Metilprednisolone Aceponato e Bepanthenol Sensiderm® utilizzati secondo due differenti modalità di applicazione, su lesioni di bambini affetti da Dermatite Atopica lieve o moderata, in fase acuta. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Children >2 and <14 years old, both sexes;
• Diagnosis of mild to moderate atopic dermatitis evaluated by means of the SCORAD index (10); SCORAD index have to be < 40;
• Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and 12) at Baseline;
• Acute symptom of pruritus at enrollment (Visit 1);
• Patients who will be enrolled should not have been on treatment with any emollient medical device for continuous period greater than 20 days;
• Ability of the participant/parents/legal guardians (in the Investigator’s opinion) to comprehend the full nature and purpose of the study;
• Consent to the study and willing to comply with all its procedures.
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1. Bambini, di entrambi i sessi, di età >2 e <14 anni;
2. Diagnosi di Dermatite Atopica lieve o moderata mediante l’indice SCORAD; tale indice deve essere <40.
3. Sintomi di Dermatite Atopica in fase acuta su ciascuna area di valutazione (indice SCORAD locale ≥ 3 and 12) al basale.
4. Sintomi acuti di prurito all’arruolamento (Visit 1);
5. I soggetto che saranno arruolati non dovranno essere stati in trattamento con alcun dispositivo medico a base di emollienti per un periodo continuativo maggiore a 20 giorni;
6. Capacità da parte dei soggetti partecipanti o dei genitori o dei rappresentanti legali (secondo il giudizio dello sperimentatore) di comprendere la natura e lo scopo dello studio;
7. Ottenimento del consenso scritto allo studio e disponibilità al rispetto di tutte le sue procedure.
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E.4 | Principal exclusion criteria |
• Patients with oozing/crusting lesions
• Chronic disease (autoimmune diseases, Chronic Obstructive Pulmonary Disease (COPD), heart disease, Chronic Renal Failure (CRF), Central Nervous System (CNS) disease, diabetes, congenital or acquired immunodeficiency;
• Known hypersensitivity or allergies to any components of the study products;
• Acute or chronic infectious diseases;
• Local therapy with corticosteroid or tacrolimus, pimecrolimus in the previous 6 weeks;
• Use of any prescription or non-prescription medication prior to baseline that could interfere with evaluations in the study
• Systemic corticosteroids within 8 weeks
• Systemic retinoids within 4 weeks
• Non-steroidal immunosuppressive treatment within 4 weeks
• Topical antibiotics, topical corticosteroids and/or topical retinoids within 2 weeks
• Participation in another clinical research study within 4 weeks before enrollment in this study
• Relatives of the investigator or site staff
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1. Soggetti che presentino lesioni essudative o con croste;
2. Presenza di malattie croniche (malattie autoimmuni, broncopneumopatia cronica ostruttiva, malattie cardiache, insufficienza renale cronica, malattie del sistema nervoso centrale, diabete, immunodeficienza congenita o acquisita;
3. Ipersensibilità o allergie note a qualsiasi componente dei prodotti in studio;
4. Malattia infettiva acuta o cronica;
5. Terapia locale con corticosteroidi, tacrolimus o pimecrolimus, nelle 6 settimane precedenti;
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E.5 End points |
E.5.1 | Primary end point(s) |
The exploratory efficacy variables will be assessed at every assessment area of each patient before and during treatment.
The following outcomes will be evaluated:
• any SCORAD change since day 0 to day 28±2;
• any PO-SCORAD change since day 0 to day 28±2;
• any LOCAL SCORAD change since day 0 to day 28±2;
• QoL change since day 0 to day 28±2;
• symptoms (itching) change since day 0 to day 28±2;
• Incidence of AEs and SAEs.
• Vital signs (blood pressure, heart rate, body temperature);
• percentage of patients that applied Bepanthenol Sensiderm® more than once a day
average number of extra application of Bepanthenol Sensiderm® per patient
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Le variabili di efficacia saranno valutate, per le aree designate di ciascun paziente, prima e durante il trattamento, secondo le seguenti modalità e i seguenti timpoints:
- qualsiasi cambiamento nell’indice SCORAD dal Giorno 0 al Giorno 28 ± 2;
- qualsiasi cambiamento nell’indice PO-SCORAD dal Giorno 0 al Giorno 28 ± 2;
- qualsiasi cambiamento nell’indice LOCAL SCORAD dal Giorno 0 al Giorno 28 ± 2;
- cambiamento nel punteggio del questionario sulla Qualità della Vita dal Giorno 0 al Giorno 28 ± 2;
- cambiamento nei sintomi (prurito) dal Giorno 0 al Giorno 28 ± 2;
- incidenza di Eventi avversi seri e non seri;
- segni vitali (pressione sangugna, frequenza cardiaca, temperatura corporea);
- percentuale di pazienti che hanno applicato Bepanthenol Sensiderm® più di una volta al giorno e media delle applicazioni extra di Bepanthenol Sensiderm® per ciascun paziente.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0 to day 28±2 |
Dal Giorno 0 al Giorno 28 ± 2 |
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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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 5 |
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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LVLP |
Ultima visita dell'ultimo paziente |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |