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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.

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.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-000409-35-IT
Enrollment
150
Registered
2016-03-15
Start date
2016-05-13
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Interventions

Trade Name: Bepanthenol Sensiderm® Product Name: Bepanthenol Sensiderm® Pharmaceutical Form: Cream Product Name: Methylprednisolone aceponate Pharmaceutical Form: Cream

Sponsors

Bambino Gesù Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Children >2 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: 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.;Secondary Objective: ;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 ;Timepoint(s) of evaluation of this end point: Day 0 to day 28±2—

Countries

Italy

Contacts

Public ContactValeria Antenucci

OPBG CRO

valeria.antenucci@opbg.net00390668593539

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026