Clinical study to compare two cutaneous emulsions with the active substance methylprednisolone aceponate 0.1% and one cutaneous emulsion without active substance for patients withatopic dermatitis

Phase 1

Conditions: Atopic dermatitis
MedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2018-001743-31-DE

Lead Sponsor: Dermapharm AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

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 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 7 days 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 mycotic skin diseases in the treatment area
• 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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of efficacy and safety of Methylprednisolone Aceponate 0.1% Cutaneous emulsion (Test) vs. Advantan Milk 0.1% Cutaneous emulsion (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis ;Secondary Objective: • Percent change of Eczema Area and Severity Index Score (EASI Score) between baseline and visits (Visit 1 and Visit 2)<br>• Percent change of the total affected body surface area (BSA) between visits (Visit 1, Visit2 and Visit 3<br>• Change of the Investigator`s Global Assessment (IGA) between visits (Visit 1, Visit2 and Visit 3<br>• Evaluation of Overall Therapeutic Success by the investigator and patient at Visit 3 (EOT)<br>• Patient´s assessment of severity of Pruritus<br>;Primary end point(s): The primary endpoint is the percent change from baseline (Visit 1) to Visit 3 (EOT) assessed by Eczema Area and Severity Index Score (EASI Score).;Timepoint(s) of evaluation of this end point: Start of therapy (Day 0) and end of therapy (Visit 3)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Percent change of Eczema Area and Severity Index Score (EASI Score) between baseline and visits (Visit 1 and Visit 2)<br>• Percent change of the total affected body surface area (BSA) between visits (Visit 1, Visit2 and Visit 3)<br>• Change of the Investigator`s Global Assessment (IGA) between visits (Visit 1, Visit2 and Visit 3)<br>• Evaluation of Overall Therapeutic Success by the investigator and patient at Visit 3 (EOT)<br>• Patient´s assessment of severity of Pruritus;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 above

Updated 5/3/2021

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Clinical study to compare two cutaneous emulsions with the active substance methylprednisolone aceponate 0.1% and one cutaneous emulsion without active substance for patients withatopic dermatitis

Recruitment & Eligibility

Study & Design

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