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July 1998

Effectiveness of the Ascomycin Macrolactam SDZ ASM 981 in the Topical Treatment of Atopic Dermatitis

Author Affiliations

From the Department of Dermatology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (Drs Van Leent, Spuls, and Bos); and the Department of Clinical Research and Development, Novartis Pharma AG, Basel, Switzerland (Drs Gräber and Wagenaar and Mr Thurston).

Arch Dermatol. 1998;134(7):805-809. doi:10.1001/archderm.134.7.805

Objective  To compare the safety and efficacy of 1% SDZ ASM 981 cream and a matching placebo cream in the treatment of patients with moderate atopic dermatitis.

Design  A randomized, double-blind, placebo-controlled, right-and-left comparison study.

Setting  Academic referral center.

Patients  Thirty-four adult patients with moderate atopic dermatitis.

Intervention  Topical 1% SDZ ASM 981 cream was applied twice daily (n=16) or once daily (n=18) and compared with a corresponding placebo cream base.

Main Outcome Measures  Efficacy was measured using a 4-point (0-3) scale for erythema, pruritus, exudation, excoriation, and lichenification (Atopic Dermatitis Severity Index [ADSI]). The ADSI score was defined as the sum of these 5 ratings (range, 0-15) and was determined on the pretreatment day (1 to 14 days before day 0) and on days 0, 2, 4, 7, 9, 11, 14, 16, 18, and 21. The percentage change from baseline (day 0) in the ADSI score was calculated on each of these days. Safety was evaluated by monitoring of adverse events, physical examination, hematologic examination, clinical chemistry studies, urinalysis, and measurement of blood levels of SDZ ASM 981.

Results  Of the 38 patients recruited, 34 started and 28 completed treatment according to the protocol. Sixteen patients used the cream twice daily, with significant improvement after 2 days of treatment. Within 3 weeks of topical therapy with 1% SDZ ASM 981 cream twice daily, a mean reduction of 71.9% in the ADSI score was observed at the actively treated test sites compared with a mean reduction of 10.3% at the placebo-treated test sites (P<.001). Efficacy was significantly less in the group treated once daily (n=18), with mean reductions of 37.7% and 6.2%, respectively. The efficacy was especially apparent for pruritus and excoriation. There were no clinically relevant drug-related adverse effects.

Conclusions  Treatment with 1% SDZ ASM 981 cream was well tolerated. Twice-daily application of 1% SDZ ASM 981 cream was significantly more effective than use of the corresponding placebo and more effective than once-daily treatment. The new macrolactam ascomycin derivative SDZ ASM 981 is a promising agent for the treatment of patients with atopic dermatitis. More elaborate phase 2 and 3 trials are under way to fully investigate the potential of this medication.