Topical methylprednisolone aceponate in an induced eczema model

Not Applicable

• Conditions: healthy participants; L29; L30; Pruritus; Other dermatitis

• Registration Number: DRKS00005608
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-05-09
• Results First Posted: 2019-08-16
• Study Start: 2021-01-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 31

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

skin disease

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speed of onset of the anti-inflammatory effect:<br> <br>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. <br>Mexameter measurement was performed before and 5, 10 and 30 minutes after cowhage application.

Secondary Outcome Measures

Name	Time	Method
effects on cowhage-induced itching on inflamed skin