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

Phase 1

Recruiting

• Conditions: Mild to moderate atopic dermatitis; MedDRA version: 21.1Level: LLTClassification code: 10003639Term: Atopic dermatitis Class: 10040785; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2024-514548-10-01
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-30
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

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

Exclusion Criteria

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, 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, 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

Study & Design

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