Clinical study to compare two cutaneous creams with the active substance methylprednisolone aceponate 0.1% and one cutaneous cream without active substance for patients with atopic dermatitis

Trial details

Who runs it

Dermapharm AG

Trial code

EU 2024-511390-30-00

Record updated

2026. október 26.

Original description

Assessment of efficacy and safety of a new methylprednisolone aceponate 0.1% cream in comparison with the approved preparation Advantan 0.1% cream and the underlying vehicle in patients with mild to moderate atopic dermatitisRead full original descriptionShow less

Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Cream (Test) vs. Advantan(R) 0.1% Cream (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis

Assessment of efficacy and safety of a new methylprednisolone aceponate 0.1% cream in comparison with the approved preparation Advantan 0.1% cream and the underlying vehicle in patients with mild to moderate atopic dermatitis

Inclusion: Women, men and children/adolescents of both sexes ≥ 6 years of age; Written consent to study participation after patient information by the investigator; In case of patients below the age of 18: Written consent to study participation of legal guardian(s) and child/adolescent patient after an age-appropriate patient- and legal guardian(s)- information session by the investigator; Acute flare of atopic dermatitis according to the Investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate)); Affected body surface (BSA) between at least 10% and not more than 40%; For women of childbearing potential: Application of an established highly efficient contraceptive method during the whole study; For all female patients of childbearing potential: Urine pregnancy test.

Exclusion: Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion; Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible; Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data; Participation in another clinical study within the last 30 days prior to inclusion in this study; Any topical treatment (e.g. topical immunomodulators such as tacrolimus ointment, pimecrolimus cream, topical antibiotics, topical glucocorticoids, other topical anti-inflammatory medication) or physical therapy (e.g. UV radiation) of the atopic dermatitis in the test area 2 weeks prior to study inclusion; Severe acute or chronic concomitant disease with severe impairment of the general condition; Presence of viral infections (such as herpes or varicella), rosacea, perioral dermatitis, ulcera, acne vulgaris, atrophic skin diseases and vaccination skin reactions in the area to be treated; Presence of bacterial and/or mycotic skin diseases in the treatment area; Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication; Reasonable doubt concerning the co-operation of the patient; Participation in this study at an earlier date; Women with existing or intended pregnancy or during lactation; Presence of tuberculous or syphilitic processes in the treatment area; Current diagnosis of glaucoma or cataract; Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations.

EU CTIS 2024-511390-30-00