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Double-blind, randomised clinical study comparing efficacy and safety of Methylprednisolone Aceponate 0.1% Ointment (Test) vs. Advantan® 0.1% Ointment (Reference) vs. Vehicle in patients with mild to moderate atopic dermatitis

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514548-10-01
Acronym
19-02/MPA-S
Enrollment
330
Registered
2024-08-13
Start date
2021-07-26
Completion date
Unknown
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate atopic dermatitis

Brief summary

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)

Detailed description

Percent change of Eczema Area and Severity Index (EASI) between visits, Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT), Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT), Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT), Patient´s assessment of severity of pruritus

Interventions

DRUGVehicle to Methylprednisolone Aceponate Ointment
DRUGMethylprednisolone Aceponate Ointment
DRUG1% Salbe

Sponsors

Dermapharm AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
Percent change of Eczema Area and Severity Index (EASI) between visits, Percent change of the total affected body surface area (BSA) between visits, and between baseline and week 3 (EOT), Change of the Investigator’s Global Assessment (IGA) between visits, and between baseline and week 3 (EOT), Evaluation of Overall Therapeutic Success by the investigator and patient at week 3 (EOT), Patient´s assessment of severity of pruritus

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026