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SDZ ASM 981: an emerging safe and effective treatment for atopic dermatitis
T Luger1, E J Van Leent, M Graeber
1Department of Dermatology, University of Muenster, Germany. luger@uni-muenster.de
The British Journal of Dermatology
|April 12, 2001
Summary
SDZ ASM 981 cream effectively treats atopic dermatitis, with the 1.0% concentration showing the best results in a dose-finding study. This well-tolerated treatment is advancing to phase III trials for inflammatory skin conditions.
Area of Science:
- Dermatology
- Immunology
- Pharmacology
Background:
- SDZ ASM 981 is a novel ascomycin macrolactam derivative.
- It selectively inhibits pro-inflammatory cytokine production from T cells and mast cells.
- This agent is under development for inflammatory skin diseases.
Purpose of the Study:
- To evaluate the safety and efficacy of SDZ ASM 981 cream at various concentrations (0.05%–1.0%).
- To identify the optimal concentration for phase III trials in atopic dermatitis patients.
Main Methods:
- A double-blind, randomized, multicentre dose-finding study.
- 260 patients received SDZ ASM 981 cream (0.05%–1.0%), vehicle, or 0.1% betamethasone-17-valerate (BMV).
- Treatment was applied twice daily for up to 3 weeks.
Main Results:
- A dose-response relationship was observed for SDZ ASM 981, with higher concentrations (0.2%–1.0%) significantly outperforming vehicle.
- The 1.0% cream demonstrated the highest efficacy in reducing Eczema Area Severity Index (EASI) and pruritus.
- SDZ ASM 981 was well tolerated, with local adverse events like burning or warmth reported more frequently at higher doses; systemic events were rare.
Conclusions:
- 1.0% SDZ ASM 981 cream was identified as the most effective and well-tolerated concentration.
- This concentration was selected for further development in phase III studies for atopic dermatitis treatment.