The novel ascomycin derivative SDZ ASM 981 is effective for psoriasis when used topically under occlusion

Authors: Mrowietz1; Graeber2; BRÄutigam3; Thurston2; Wagenaar2; Weidinger3; Christophers1

Source: British Journal of Dermatology, Volume 139, Number 6, December 1998 , pp. 992-996(5)

Publisher: Blackwell Publishing

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Abstract:

Topical SDZ ASM 981 has been found to be highly effective in preclinical models of T-cell-mediated skin disease. T cell activation is crucial in the pathogenesis of psoriasis. It has been hypothesized that SDZ ASM 981 may prove to be an effective treatment for chronic plaque psoriasis. Therefore, the study objective was to determine the efficacy, tolerability and safety of the new topical macrolactam, SDZ ASM 981, for chronic plaque psoriasis. Ten patients with chronic plaque-type psoriasis were treated with SDZ ASM 981 (0.3% and 1.0%), the corresponding ointment base (placebo) and open-labelled clobetasol-17-propionate ointment (0.05%) in a randomized, double-blind, within-subject comparison for 2 weeks using the microplaque assay. Evaluation was performed by daily determination of clinical scores for erythema and induration. The results of the study showed that, after 2 weeks of treatment, total scores decreased by 92% for clobetasol, by 82% for 1% SDZ ASM 981, by 63% for 0.3% SDZ ASM 981 and by 18% for the ointment base (placebo). No adverse drug effects were seen in any patient throughout the study. We conclude from our results that the new macrolactam SDZ ASM 981 (1%) is similar to clobetasol-17-propionate (0.05%) in plaque-type psoriasis when applied topically under occlusion for 2 weeks using the microplaque assay.

Document Type: Original article

DOI: 10.1046/j.1365-2133.1998.02554.x

Affiliations: 1: Department of Dermatology, University of Kiel, Schittenhelmstr. 7, 24105 Kiel, Germany, 2: Research and Development, Novartis Pharma, Basle, Switzerland, 3: Clinical Research, Novartis Pharma, Nürnberg, Germany

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