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 dermatiits.

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-002686-35-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-09
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• 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 with negative result prior to study start

Are the trial subjects under 18? yes
Number of subjects for this age range: 330
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion
• 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
• Presence of tuberculous or syphilitic processes in the treatment area
• 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
• Current diagnosis of glaucoma or cataract
• Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication
• Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations
• Severe acute or chronic concomitant disease with severe impairment of the general condition
• 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
• Reasonable doubt concerning the co-operation of the patient
• Participation in another clinical study within the last 30 days prior to inclusion in this study
• Participation in this study at an earlier date
• Women with existing or intended pregnancy or during lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified