Abstract
The aim of the controlled double-blind trial in patients with atopic dermatitis was the evaluatuion of efficacy of the combination of levomenol and heparin compared to the two single active substances alone and the cream base. Patients and Methods: 278 patients were randomized to four groups: 79 patients were treated with a combination preparation from levomenol and heparin, 80 with levomenol alone, 78 with heparin alone, and 41 with the cream base without active substances.
The cream was applied twice daily for 8 weeks. Efficacy criteria were the severity of pruritus (visual analogue scale) and the SCORAD index as well as the overall assessment of efficacy and tolerance by the physician and patient.
Results: The improvement of pruritus and SCORAD values in the combination preparation group was significantly superior compared to all other groups (ANCOVA, p <7x108). The improvement of pruritus under treatment with the combination approximately corresponded to the cumulative effect of the two single active substances.
Conclusion: The combination of levomenol and heparin proved to be significantly more efficacious against pruritus and inflamed skin than preparations of the single components