Topical methylprednisolone aceponate in an induced eczema model

Topical methylprednisolone aceponate in an induced eczema model - TOM-IE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005608

Enrollment

Registered

2021-01-26

Start date

2013-12-18

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

healthy participants L29 L30

Interventions

Group 1: Trigger eczema, trigger itching Advantan cream (methylprednisolone aceponate), approx. 15cm2 once daily, for 5 days, 0.1% Group 2: Trigger eczema, trigger itching Advabase cream (basic cream,

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Healthy, caucasian, male and female adult volunteers, aged between 18 and 60 years (in total 30) will be recruited for this study. Written informed consent Fitzpatrick skin type II – III; patients demonstrating irritative skin reaction to 24 h occluded epicutaneous test with 1 % SLS, i.e. ‘responders’;

Exclusion criteria

Exclusion criteria: skin disease

Design outcomes

Primary

Measure	Time frame
Speed of onset of the anti-inflammatory effect: To assess the speed of onset of the anti-inflammatory effect of a topical treatment with methylprednisolone aceponate ointment 0.1% (Advantan® creme) vs. placebo in an induced eczema Inflammatory response will be evaluated using Mexameter measurement and a clinical score. AUC and peak response will be assessed as well as clinical examination using a score. A comparison at different time points for verum and placebo will be performed. Mexameter measurement was performed before and 5, 10 and 30 minutes after cowhage application.	—

Measure

Time frame

Speed of onset of the anti-inflammatory effect: To assess the speed of onset of the anti-inflammatory effect of a topical treatment with methylprednisolone aceponate ointment 0.1% (Advantan® creme) vs. placebo in an induced eczema Inflammatory response will be evaluated using Mexameter measurement and a clinical score. AUC and peak response will be assessed as well as clinical examination using a score. A comparison at different time points for verum and placebo will be performed. Mexameter measurement was performed before and 5, 10 and 30 minutes after cowhage application.

—

Secondary

Measure	Time frame
effects on cowhage-induced itching on inflamed skin	—

Countries

Germany

Contacts

Public ContactAdrian Post

Dermatologie, Charité - Universitätsmedizin Berlin

adrian.post@charite.de030 450 518217

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026