METHYLPREDNISOLONE ACEPONATE for Mild to moderate atopic dermatitis | Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- Women, men and children/adolescents of ≥ 6 years of age"}
• {"criterion_text":"- Written consent to study participation after patient information by the investigator"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Acute flare of atopic dermatitis according to the Investigator´s Global Assessment (IGA score 2 (mild) or 3 (moderate))"}
• {"criterion_text":"- Affected body surface (BSA) between at least 10% and not more than 40%"}
• {"criterion_text":"- For women of childbearing potential1: Application of an established highly efficient contraceptive method2 during the whole study"}
• {"criterion_text":"- For all female patients of childbearing potential: Urine pregnancy test with negative result prior to study start"}

Exclusion criteria

• {"criterion_text":"- Any systemic treatment of the atopic dermatitis within the last 4 weeks prior to study inclusion"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data"}
• {"criterion_text":"- Reasonable doubt concerning the co-operation of the patient"}
• {"criterion_text":"- Participation in another clinical study within the last 30 days prior to inclusion in this study"}
• {"criterion_text":"- Participation in this study at an earlier date"}
• {"criterion_text":"- Women with existing or intended pregnancy or during lactation"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Presence of tuberculous or syphilitic processes in the treatment area"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Presence of bacterial and/or mycotic skin diseases in the treatment area"}
• {"criterion_text":"- Current diagnosis of glaucoma or cataract"}
• {"criterion_text":"- Known intolerance or hypersensitivity against methylprednisolone aceponate or any of the other ingredients in the study medication"}
• {"criterion_text":"- Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area, which would interfere with evaluations"}
• {"criterion_text":"- Severe acute or chronic concomitant disease with severe impairment of the general condition"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study is the percent change from baseline (Visit 1) to Visit 4 (EOT) assessed by Eczema Area and Severity Index (EASI)","definition_or_measurement_approach":"Percent change from baseline (Visit 1) to Visit 4 (EOT) measured using the Eczema Area and Severity Index (EASI)"}

Secondary endpoints

• {"endpoint_text":"- Percent change of Eczema Area and Severity Index (EASI) between visits","definition_or_measurement_approach":"Measured as percent change in EASI score between visits"}
• {"endpoint_text":"- Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT)","definition_or_measurement_approach":"Measured as percent change in affected body surface area (BSA) between visits and between baseline and week 3 (end of treatment)"}
• {"endpoint_text":"- Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT)","definition_or_measurement_approach":"Change in Investigator's Global Assessment (IGA) score between visits and between baseline and week 3 (EOT)"}
• {"endpoint_text":"- Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT)","definition_or_measurement_approach":"Investigator and patient evaluation of overall therapeutic success at week 3 (EOT); measurement approach per investigator/patient assessments"}
• {"endpoint_text":"- Patient´s assessment of severity of pruritus","definition_or_measurement_approach":"Patient-reported assessment of pruritus severity (method as per protocol patient-reported outcome instrument)"}

Germany

Earliest CTIS Part Ii Submission Date

07-08-2024

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

616

Number Of Sites

12

Number Of Participants

330

Primary sponsor

Full Name

Dermapharm AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

GKM Gesellschaft fuer Therapieforschung mbH

Responsibilities

Sponsor duties codes: 10,11,6,7 (as listed in CTIS record)

Name

Symbio Clinical Research GmbH

Responsibilities

Sponsor duties codes: 1,2 (as listed in CTIS record)

Third parties

• {"country":"Germany","full_name":"GKM Gesellschaft fuer Therapieforschung mbH","duties_or_roles":"Codes: 10,11,6,7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Symbio Clinical Research GmbH","duties_or_roles":"Codes: 1,2","organisation_type":"Pharmaceutical company"}