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

Prior treatment

• 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

Other illness

• 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

Other

• 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

• Women, men and children/adolescents of ≥ 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 potential1: Application of an established highly efficient contraceptive method2 during the whole study
• For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start