Explorative study on the clinical efficacy and tolerability of methylprednisolone aceponate cream and a new topical medical device in paediatric patients with mild to moderate Atopic Dermatitis, testing two different application modalities in the same patient on flexural contralateral lesions.

Phase 1

Conditions: Atopic Dermatitis
Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Registration Number: EUCTR2016-000409-35-IT

Lead Sponsor: Bambino Gesù Children's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 150

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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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