Methylprednisolone aceponate for Atopic dermatitis | Mild to moderate atopic dermatitis

Inclusion criteria

• {"criterion_text":"- Women, men and children/adolescents of both sexes ≥ 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 potential: Application of an established highly efficient contraceptive method during the whole study"}
• {"criterion_text":"- For all female patients of childbearing potential: Urine pregnancy test"}

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 Score (EASI Score)","definition_or_measurement_approach":"Percent change from baseline (Visit 1) to Visit 4 (End of Treatment) assessed using the Eczema Area and Severity Index (EASI) score."}

Secondary endpoints

• {"endpoint_text":"- Percent change of Eczema Area and Severity Index Score (EASI Score) between baseline (Visit 1) and Visit 2 and Visit 3","definition_or_measurement_approach":"Percent change in EASI score between baseline and Visit 2 and Visit 3."}
• {"endpoint_text":"- Percent change of the total affected body surface area (BSA) between baseline (Visit 1) and Visit 2, Visit 3 and Visit 4","definition_or_measurement_approach":"Percent change in total affected BSA between baseline and Visits 2, 3, and 4 (EoT)."}
• {"endpoint_text":"- Change of the Investigator's Global Assessment (IGA) between baseline (Visit 1) and Visit 2, Visit 3 and Visit 4","definition_or_measurement_approach":"Change in Investigator's Global Assessment (IGA) score between baseline and Visits 2, 3, and 4."}
• {"endpoint_text":"- Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT)","definition_or_measurement_approach":"Investigator and patient assessment of overall therapeutic success at Week 3 (End of Treatment)."}
• {"endpoint_text":"- Patient´s assessment of severity of pruritus at visits (Visit 1, Visit 2, Visit 3 and Visit 4)","definition_or_measurement_approach":"Patient-reported assessment of pruritus severity at Visits 1–4."}

Methods

• Poster and flyer materials (document: K2_MPA-C_RecruitmenMaterial_Poster Flyer Design) - general public/potential patient recruitment
• Referral letters to physicians (document: K2_MPA-C_RecruitmenMaterial_Referral Letter) - targeting referring clinicians
• Newspaper advertisements (document: K2_MPA-C_RecruitmentMaterial_Newspaper) - general public outreach
• Study-specific informed consent and patient information materials for adults, parents, adolescents and children (documents listed) used during site-based recruitment

Germany

Earliest CTIS Part Ii Submission Date

31-01-2024

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

805

Number Of Sites

11

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

10,11,6,7

Name

Symbio Clinical Research GmbH

Responsibilities

1,2

Third parties

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